There were 183 companies in cities associated with Miami-Dade County that received FDA citations as a result of 189 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 44.1% increase over the number of companies cited in the previous year.
Of the 570 citations issued, the most common citation was ‘You did not develop an FSVP’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Drugs sector.
Of the companies cited, 173 should take voluntary actions to correct their managing operations (94.5%). Additionally, 11 companies had to take regulatory and/or administrative actions (6%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Companies Located within Miami-Dade County Cities and the Citations They Received in 2025
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| 305 Import & Export, LLC | Food and Cosmetics | 05/15/2025 | Record – available |
| Advanced Instrumentations, Inc. | Devices | 04/17/2025 | Management ensuring quality policy is understood |
| Advanced Instrumentations, Inc. | Devices | 04/17/2025 | Design history file |
| Advanced Instrumentations, Inc. | Devices | 04/17/2025 | Procedures not adequately established or maintained |
| Advanced Instrumentations, Inc. | Devices | 04/17/2025 | Purchasing controls, Lack of or inadequate procedures |
| Advanced Instrumentations, Inc. | Devices | 04/17/2025 | Complaints |
| All Over Import & Export, Inc. | Food and Cosmetics | 05/02/2025 | Personnel |
| American Global Handlers, Inc. | Food and Cosmetics | 12/05/2025 | Importer verification |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Specifications – components |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Specifications – finished dietary supplement |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Appropriate tests, examinations; certificate of analysis |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Reserve sample – container-closure system |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Quality control – reserve samples |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Master manufacturing record – prepared |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Master manufacturing record – specifications, quality; packaging, labeling |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Master manufacturing record – record requirements |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Batch record – follow master |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Batch record – required information |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Standard reference materials; criteria for selecting |
| American Natural Products, Inc. | Food and Cosmetics | 07/11/2025 | Examination, testing; appropriate |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Qualifications of individuals |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Personnel |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Sanitary operations – Plant sanitation |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Equipment and utensils – Design and maintenance |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Plant operations – Precautions |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Manufacturing, processing, packing, holding – Controls |
| Angel Food, LLC | Food and Cosmetics | 10/24/2025 | Record availability |
| Angelita Tortilleria, Inc. | Food and Cosmetics | 12/04/2025 | Personnel |
| Angelita Tortilleria, Inc. | Food and Cosmetics | 12/04/2025 | Sanitary operations – Plant sanitation |
| Angelita Tortilleria, Inc. | Food and Cosmetics | 12/04/2025 | Sanitary facilities and controls |
| Ansa Financial Consulting, LLC | Food and Cosmetics | 11/05/2025 | Sanitation of food-contact surfaces – Frequency |
| Ansa Financial Consulting, LLC | Food and Cosmetics | 11/05/2025 | Equipment and utensils – Design and maintenance |
| Applied Consumer Services, Inc. | Drugs | 09/29/2025 | Control / Lab Operations Area |
| Applied Consumer Services, Inc. | Drugs | 09/29/2025 | Written procedures fail to include |
| Applied Consumer Services, Inc. | Drugs | 09/29/2025 | Sample identification and other information |
| Aquabest Seafood, LLC | Food and Cosmetics | 07/22/2025 | Importer verification |
| Arizona Nutritional Supplements, LLC | Food and Cosmetics | 07/23/2025 | Metal, foreign material |
| Arizona Nutritional Supplements, LLC | Food and Cosmetics | 07/23/2025 | Product complaint – qualified person review & investigate |
| Atlantic Sapphire USA, LLC | Food and Cosmetics | 05/21/2025 | Food safety hazards |
| Atlantic Sapphire USA, LLC | Food and Cosmetics | 05/21/2025 | Corrective action plan |
| Atlantic Sapphire USA, LLC | Food and Cosmetics | 05/21/2025 | Corrective action per predetermined plan |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications – components |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications – finished dietary supplement |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Component – verify identity, dietary ingredient |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications met – verify; production, process control |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Batch record – required information |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications – components |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications – finished dietary supplement |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Appropriate tests, examinations; certificate of analysis |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Specifications met – verify; production, process control |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Master manufacturing record – prepared |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Criteria for establishing specifications |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Standard reference materials; criteria for selecting |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Examination, testing; established criteria |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Examination, testing; scientifically valid |
| Avanti Nutritional Laboratories | Food and Cosmetics | 03/11/2025 | Manufacturing operations – sanitation |
| Barzu Internacional, LLC | Food and Cosmetics | 05/19/2025 | Sanitary operations – Plant maintenance |
| Black Pearl Seafood Enterprise, LLC | Food and Cosmetics | 02/11/2025 | Importer verification |
| Blue Roof Brands, LLC | Food and Cosmetics | 08/08/2025 | Hazard analysis written |
| Blue Roof Brands, LLC | Food and Cosmetics | 08/08/2025 | Document review entity’s hazard analysis |
| Blue Roof Brands, LLC | Food and Cosmetics | 08/08/2025 | Evaluation – performance, risk |
| Blue Roof Brands, LLC | Food and Cosmetics | 08/08/2025 | Verification activity before import, periodically |
| Brain Child Nutritionals, LLC | Food and Cosmetics | 06/26/2025 | Specifications – finished dietary supplement |
| Brain Child Nutritionals, LLC | Food and Cosmetics | 06/26/2025 | Component – qualify supplier |
| Brain Child Nutritionals, LLC | Food and Cosmetics | 06/26/2025 | Reserve sample – collect, hold |
| Brain Child Nutritionals, LLC | Food and Cosmetics | 06/26/2025 | Make and keep records – returned dietary supplements |
| Brain Tunnelgenix Technologies | Devices | 01/31/2025 | Maintained |
| Burtoni Group Corporation | Food and Cosmetics | 02/12/2025 | Develop FSVP |
| CNB Quality Food, Corp. | Food and Cosmetics | 08/14/2025 | Personnel |
| CNB Quality Food, Corp. | Food and Cosmetics | 08/14/2025 | Manufacturing, processing, packing, holding – Controls |
| Carmela Desserts, LLC | Food and Cosmetics | 07/23/2025 | Sanitary operations – Plant sanitation |
| Carmela Desserts, LLC | Food and Cosmetics | 07/23/2025 | Pest control |
| Carmela Desserts, LLC | Food and Cosmetics | 07/23/2025 | Sanitation of food-contact surfaces – Frequency |
| Castillo Distribution, Inc. | Food and Cosmetics | 11/05/2025 | Verification – record review – frequency |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Personnel |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Toxic chemicals – Identified, held, stored |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Sanitation of food-contact surfaces – Frequency |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Sanitary facilities and controls |
| Catao Market, LLC | Food and Cosmetics | 12/19/2025 | Equipment and utensils – Design and maintenance |
| Celorrio USA, Inc. | Food and Cosmetics | 07/16/2025 | Pest control |
| Celorrio USA, Inc. | Food and Cosmetics | 07/16/2025 | Storage and Distribution |
| Century Farms International | Food and Cosmetics | 04/24/2025 | Develop FSVP |
| Chemco Corporation | Drugs | 08/22/2025 | Written procedures not established/followed |
| Chemco Corporation | Drugs | 08/22/2025 | Computer control of master formula records |
| Chemco Corporation | Drugs | 08/22/2025 | Reports of Analysis (Components) |
| Chemco Corporation | Drugs | 08/22/2025 | Absence of Written Procedures |
| Chemco Corporation | Drugs | 08/22/2025 | Scientifically sound laboratory controls |
| Chemco Corporation | Drugs | 08/22/2025 | Annual visual exams of drug products |
| Chemco Corporation | Drugs | 08/22/2025 | Review of representative number of batches |
| Chemco Corporation | Drugs | 08/22/2025 | Investigations of discrepancies, failures |
| Claor Consulting, LLC | Food and Cosmetics | 04/03/2025 | Not registered |
| Claor Consulting, LLC | Food and Cosmetics | 04/03/2025 | Develop FSVP |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Process filing |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Quality control procedures |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Code – required elements |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Process deviations- identification and records |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Pest control |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Hazard analysis – Identification of hazard |
| Corporate American Solutions, LLC | Food and Cosmetics | 01/31/2025 | Specifications – labels, packaging |
| Corporate American Solutions, LLC | Food and Cosmetics | 01/31/2025 | Quality control operations; written procedures; material review, disposition |
| Corporate American Solutions, LLC | Food and Cosmetics | 01/31/2025 | Records – written procedures holding and distribution; product distribution |
| Corporate American Solutions, LLC | Food and Cosmetics | 01/31/2025 | Make and keep records – returned dietary supplements |
| Corporate American Solutions, LLC | Food and Cosmetics | 01/31/2025 | Records – written procedures; product complaint |
| Cosmecare Technician International, Corp. | Food and Cosmetics | 06/24/2025 | Specifications – finished dietary supplement |
| Cosmecare Technician International, Corp. | Food and Cosmetics | 06/24/2025 | Component – qualify supplier |
| D’Fresh Produce, Corp. | Food and Cosmetics | 03/26/2025 | Develop FSVP |
| David’s Food & Fun, Inc. | Food and Cosmetics | 06/20/2025 | Personnel |
| David’s Food & Fun, Inc. | Food and Cosmetics | 06/20/2025 | Sanitation of food-contact surfaces – Frequency |
| Delta Labs of South Florida, Corp. | Drugs | 07/08/2025 | Authority lacking to review records, investigate errors |
| Delta Labs of South Florida, Corp. | Drugs | 07/08/2025 | Complete test data included in records |
| Delta Labs of South Florida, Corp. | Drugs | 07/08/2025 | Laboratory Test Method Verification |
| Dibe, LLC | Food and Cosmetics | 12/02/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Dibe, LLC | Food and Cosmetics | 12/02/2025 | Storage and Distribution |
| Dibe, LLC | Food and Cosmetics | 12/02/2025 | Modified requirement: Temperature control – Implement |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Develop FSVP |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Qualified individual FSVP activities |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Evaluation – performance, risk |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Continue to import, change activities |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Audit – food safety regulation, plan |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Identification – entry |
| Double Way, Corp. | Food and Cosmetics | 05/14/2025 | Record – translate to English |
| Drink Robust Miami | Food and Cosmetics | 08/21/2025 | Pest control |
| Drink Robust Miami | Food and Cosmetics | 08/21/2025 | Storage and Distribution |
| El Maguey Dorado Corporation | Food and Cosmetics | 05/02/2025 | Personnel |
| El Maguey Dorado Corporation | Food and Cosmetics | 05/02/2025 | Sanitary operations – Plant sanitation |
| El Norteno Distributor, Corp. | Food and Cosmetics | 02/10/2025 | Develop FSVP |
| Evi International Group, LLC | Drugs | 01/15/2025 | Procedures not in writing, fully followed |
| Evi International Group, LLC | Drugs | 01/15/2025 | Cleaning / Sanitizing / Maintenance |
| Evi International Group, LLC | Drugs | 01/15/2025 | Calibration/Inspection/Checking not done |
| Evi International Group, LLC | Drugs | 01/15/2025 | Computer control of master formula records |
| Evi International Group, LLC | Drugs | 01/15/2025 | Reports of Analysis (Components) |
| Evi International Group, LLC | Drugs | 01/15/2025 | Control procedures to monitor and validate performance |
| Evi International Group, LLC | Drugs | 01/15/2025 | Scientifically sound laboratory controls |
| Evi International Group, LLC | Drugs | 01/15/2025 | Testing and release for distribution |
| Evi International Group, LLC | Drugs | 01/15/2025 | Lack of written stability program |
| Evi International Group, LLC | Drugs | 01/15/2025 | Dates not included for each significant step |
| Evi International Group, LLC | Food and Cosmetics | 05/02/2025 | Specifications – finished dietary supplement |
| Evi International Group, LLC | Food and Cosmetics | 05/02/2025 | Records – make and keep |
| Evi International Group, LLC | Food and Cosmetics | 05/02/2025 | Metal, foreign material |
| Evi International Group, LLC | Food and Cosmetics | 05/02/2025 | Manufacturing, processing, packing, holding – Controls |
| Excelsior Labs, Inc. | Food and Cosmetics | 06/12/2025 | Specifications – finished dietary supplement |
| Excelsior Labs, Inc. | Food and Cosmetics | 06/12/2025 | Reserve sample – collect, hold |
| Excelsior Labs, Inc. | Food and Cosmetics | 06/12/2025 | Returned dietary supplement – material review, disposition |
| Excelsior Labs, Inc. | Food and Cosmetics | 06/12/2025 | Make and keep records – returned dietary supplements |
| Exim Direct, Corp. | Food and Cosmetics | 04/02/2025 | Develop FSVP |
| FG Enterprise USA, LLC | Food and Cosmetics | 06/02/2025 | Develop FSVP |
| Farmasi US, LLC | Food and Cosmetics | 03/19/2025 | Develop FSVP |
| Farmasi US, LLC | Food and Cosmetics | 11/05/2025 | Develop FSVP |
| Ferney, LLC | Food and Cosmetics | 07/31/2025 | Personnel |
| Ferney, LLC | Food and Cosmetics | 07/31/2025 | Sanitary operations – Plant maintenance |
| Ferney, LLC | Food and Cosmetics | 07/31/2025 | Sanitary operations – Plant sanitation |
| Ferney, LLC | Food and Cosmetics | 07/31/2025 | Toxic chemicals – Identified, held, stored |
| Ferney, LLC | Food and Cosmetics | 07/31/2025 | Manufacturing, processing, packing, holding – Controls |
| Flanigan’s Fish Company, LLC | Food and Cosmetics | 12/16/2025 | HACCP plan implementation |
| Flanigan’s Fish Company, LLC | Food and Cosmetics | 12/16/2025 | Sanitation monitoring documentation |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Contact surfaces – low moisture products |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Specifications – components |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Specifications – labels, packaging |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Specifications – finished dietary supplement |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Written procedures – establish; quality control operations |
| Flax & More Corporation | Food and Cosmetics | 10/29/2025 | Quality control – reject; specification not met |
| Florida Veg Investments, LLC | Food and Cosmetics | 09/04/2025 | Manufacturing, processing, packing, holding – Controls |
| Flowers Baking Company of Miami, LLC | Food and Cosmetics | 08/22/2025 | Personnel |
| Flowers Baking Company of Miami, LLC | Food and Cosmetics | 08/22/2025 | Plant construction and design |
| Flowers Baking Company of Miami, LLC | Food and Cosmetics | 08/22/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Flowers Baking Company of Miami, LLC | Food and Cosmetics | 08/22/2025 | Equipment and utensils – Design and maintenance |
| Flowers Baking Company of Miami, LLC | Food and Cosmetics | 08/22/2025 | Process control – Foreign objects |
| Focalyx Technologies, LLC. | Devices | 12/01/2025 | Label to bear a unique device identifier |
| Focalyx Technologies, LLC. | Devices | 12/01/2025 | Design validation – user needs and intended uses |
| Foresta Foods, Inc. | Food and Cosmetics | 08/12/2025 | Hazard analysis written |
| Foresta Foods, Inc. | Food and Cosmetics | 08/12/2025 | Document review entity’s hazard analysis |
| Foresta Foods, Inc. | Food and Cosmetics | 08/12/2025 | Approved supplier procedures – importer established |
| Foresta Foods, Inc. | Food and Cosmetics | 08/12/2025 | Supplier verification – establish written procedures |
| Foresta Foods, Inc. | Food and Cosmetics | 08/12/2025 | Verification activity assurance |
| Foresta Foods, Inc. | Veterinary | 08/12/2025 | Hazard analysis written |
| Foresta Foods, Inc. | Veterinary | 08/12/2025 | Document review entity’s hazard analysis |
| Foresta Foods, Inc. | Veterinary | 08/12/2025 | Approved supplier procedures – importer established |
| Foresta Foods, Inc. | Veterinary | 08/12/2025 | Supplier verification – establish written procedures |
| Foresta Foods, Inc. | Veterinary | 08/12/2025 | Verification activity assurance |
| Frank’S Produce of Miami, Inc. | Food and Cosmetics | 11/20/2025 | Develop FSVP |
| French Gluten Free, Inc. | Food and Cosmetics | 07/22/2025 | Hazard analysis biological, chemical, physical |
| French Gluten Free, Inc. | Food and Cosmetics | 07/22/2025 | Document review entity’s hazard analysis |
| French Gluten Free, Inc. | Food and Cosmetics | 07/22/2025 | Supplier verification – establish written procedures |
| French Gluten Free, Inc. | Food and Cosmetics | 07/22/2025 | Verification activity before import, periodically |
| From the South Investments, LLC | Food and Cosmetics | 03/11/2025 | Hazard analysis biological, chemical, physical |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Develop FSVP |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Document review entity’s hazard analysis |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Evaluation – performance, risk |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Supplier approval – document |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Unapproved supplier procedures – importer established |
| Fronterra Group, Inc. | Food and Cosmetics | 06/02/2025 | Identification – entry |
| Fruitbreeze, LLC | Food and Cosmetics | 03/07/2025 | Document review entity’s hazard analysis |
| Fruitbreeze, LLC | Food and Cosmetics | 03/07/2025 | Supplier approval – document |
| Fruitbreeze, LLC | Food and Cosmetics | 03/07/2025 | Verification activity frequency |
| Fruitbreeze, LLC | Food and Cosmetics | 03/07/2025 | Audit – food safety regulation, plan |
| GLC Abroad, LLC | Food and Cosmetics | 02/04/2025 | Develop FSVP |
| Gelato Italiano USA, Corp. | Food and Cosmetics | 04/29/2025 | Develop FSVP |
| Genfoods, Inc. | Food and Cosmetics | 08/19/2025 | Modified requirement: Temperature control – Implement |
| Good Rice, LLC | Food and Cosmetics | 07/11/2025 | Hazard analysis written |
| Guuao, LLC. | Food and Cosmetics | 09/25/2025 | Hazard analysis biological, chemical, physical |
| Guuao, LLC. | Food and Cosmetics | 09/25/2025 | Document review entity’s hazard analysis |
| Harvest Valley, Inc. | Food and Cosmetics | 07/09/2025 | No HACCP plan |
| Harvest Valley, Inc. | Food and Cosmetics | 07/09/2025 | Sanitation Records |
| Harvest Valley, Inc. | Food and Cosmetics | 07/09/2025 | Importer verification |
| Home of Gelato | Food and Cosmetics | 02/13/2025 | Plant construction and design |
| I. C. Distributor, LLC | Food and Cosmetics | 11/06/2025 | Personnel |
| I. C. Distributor, LLC | Food and Cosmetics | 11/06/2025 | Sanitary operations – Plant maintenance |
| I. C. Distributor, LLC | Food and Cosmetics | 11/06/2025 | Sanitary operations – Plant sanitation |
| I. C. Distributor, LLC | Food and Cosmetics | 11/06/2025 | Manufacturing, processing, packing, holding – Controls |
| I. C. Distributor, LLC | Food and Cosmetics | 11/06/2025 | Record availability |
| Idalia A. Acosta, M.D. | Drugs | 01/16/2025 | Case history records- inadequate or inadequate |
| Iguana Coo, Corp. | Food and Cosmetics | 06/13/2025 | Develop FSVP |
| Imperial Bakery, Inc. | Food and Cosmetics | 02/04/2025 | Personnel |
| Imperial Bakery, Inc. | Food and Cosmetics | 02/04/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Imperial Bakery, Inc. | Food and Cosmetics | 02/04/2025 | Sanitation of food-contact surfaces – Frequency |
| Imperial Bakery, Inc. | Food and Cosmetics | 02/04/2025 | Storage and Distribution |
| Inexport Logistics, LLC | Food and Cosmetics | 10/01/2025 | Modified requirement: Temperature control – Implement |
| Ionetix Corporation | Drugs | 05/01/2025 | Lack Adequate Resources, Facilities, Equipment. |
| Ionetix Corporation | Drugs | 05/01/2025 | Orderly handling, prevention of mix-ups, prevention of contamination |
| Ionetix Corporation | Drugs | 05/01/2025 | Equipment procedures |
| Ionetix Corporation | Drugs | 05/01/2025 | Analytical methods |
| Ionetix Corporation | Drugs | 05/01/2025 | Correction of problems |
| Ionetix Corporation | Drugs | 09/26/2025 | Lack Adequate Resources, Facilities, Equipment. |
| Ionetix Corporation | Drugs | 09/26/2025 | Written QA procedures established, followed |
| Ionetix Corporation | Drugs | 09/26/2025 | Orderly handling, prevention of mix-ups, prevention of contamination |
| Ionetix Corporation | Drugs | 09/26/2025 | Equipment procedures |
| Ionetix Corporation | Drugs | 09/26/2025 | Written procedures for control of components, containers, and closures |
| Ionetix Corporation | Drugs | 09/26/2025 | Use of reliable suppliers |
| Irene Melo Nutrition, Inc. | Food and Cosmetics | 12/03/2025 | Written procedures – establish; holding and distribution |
| Irene Melo Nutrition, Inc. | Food and Cosmetics | 12/03/2025 | Written procedures – establish; returned dietary supplements |
| Irene Melo Nutrition, Inc. | Food and Cosmetics | 12/03/2025 | Written procedures – establish; product complaint |
| Island Spice Jamaica, Inc. | Food and Cosmetics | 07/18/2025 | Develop FSVP |
| JAS Diagnostics/Drew Scientific, Inc., Inc. | Devices | 06/12/2025 | Training records |
| JAS Diagnostics/Drew Scientific, Inc., Inc. | Devices | 06/12/2025 | Design control – no procedures |
| JAS Diagnostics/Drew Scientific, Inc., Inc. | Devices | 06/12/2025 | Purchasing controls, Lack of or inadequate procedures |
| JAS Diagnostics/Drew Scientific, Inc., Inc. | Devices | 06/12/2025 | Lack of or inadequate process validation |
| JAS Diagnostics/Drew Scientific, Inc., Inc. | Devices | 06/12/2025 | Complaints |
| JD Brokers Forwarding Company | Food and Cosmetics | 12/15/2025 | Pest control |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Hazard analysis written |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Document review entity’s hazard analysis |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Supplier approval – document |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Reevaluate – 3 years |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Approved supplier procedures – importer established |
| JMA Import & Export, LLC. | Food and Cosmetics | 04/03/2025 | Supplier verification – establish written procedures |
| Kappa Laboratories, Inc. | Drugs | 06/04/2025 | Calibration/Inspection/Checking not done |
| Kappa Laboratories, Inc. | Drugs | 06/04/2025 | Establishment of calibration procedures |
| Kappa Laboratories, Inc. | Drugs | 06/04/2025 | No written record of investigation |
| Kat International Corporation | Food and Cosmetics | 05/21/2025 | Plant construction and design |
| Kat International Corporation | Food and Cosmetics | 05/21/2025 | Pest control |
| Kat International Corporation | Food and Cosmetics | 05/21/2025 | Storage and Distribution |
| Kessep Dermaceuticals, Inc. | Food and Cosmetics | 09/05/2025 | Unsafe color additive |
| Kool-Veg, Inc. | Food and Cosmetics | 12/17/2025 | Plant construction and design |
| Krystal Logistics USA, Inc. | Food and Cosmetics | 06/18/2025 | Sanitary operations – Plant maintenance |
| LA Bendicion Foods, LLC. | Food and Cosmetics | 03/10/2025 | Develop FSVP |
| LA Bendicion Foods, LLC. | Food and Cosmetics | 03/10/2025 | Approved supplier procedures – importer established |
| LA Bendicion Foods, LLC. | Food and Cosmetics | 03/10/2025 | Record – translate to English |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Qualifications of individuals |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Personnel |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Sanitation of food-contact surfaces – Frequency |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Equipment and utensils – Design and maintenance |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Raw materials – Allergen identification |
| LA Provence French Bakery-Wholesale, LLC | Food and Cosmetics | 06/17/2025 | Manufacturing, processing, packing, holding – Controls |
| La Crocante Fine Foods Distributor, LLC | Food and Cosmetics | 03/10/2025 | Hazard analysis – Identification of hazard |
| La Crocante Fine Foods Distributor, LLC | Food and Cosmetics | 03/10/2025 | Process preventive controls – Implement |
| La Crocante Fine Foods Distributor, LLC | Food and Cosmetics | 03/10/2025 | Sanitation preventive controls – Implement |
| La Nica Products, Inc. | Food and Cosmetics | 06/11/2025 | Sanitary operations – Plant maintenance |
| La Real Foods, Inc. | Food and Cosmetics | 09/18/2025 | Hazard analysis – Identification of hazard |
| La Real Foods, Inc. | Food and Cosmetics | 09/18/2025 | Process preventive controls – Implement |
| Lamex Agrifoods, Inc. | Food and Cosmetics | 06/06/2025 | Evaluation – performance, risk |
| Lamex Agrifoods, Inc. | Food and Cosmetics | 06/06/2025 | Record – sign, date |
| Lempira Distribution, LLC | Food and Cosmetics | 07/23/2025 | Develop FSVP |
| Life Products, LLC | Food and Cosmetics | 02/07/2025 | Document review entity’s hazard analysis |
| Life Products, LLC | Food and Cosmetics | 02/07/2025 | Evaluation – performance, risk |
| Life Products, LLC | Food and Cosmetics | 02/07/2025 | Supplier verification – establish written procedures |
| Life Products, LLC | Food and Cosmetics | 02/07/2025 | Verification activity before import, periodically |
| Llorens Pharmaceuticals International Division, Inc. | Drugs | 05/15/2025 | Procedures not in writing, fully followed |
| Llorens Pharmaceuticals International Division, Inc. | Drugs | 05/15/2025 | Valid stability test methods |
| Llorens Pharmaceuticals International Division, Inc. | Food and Cosmetics | 09/26/2025 | Specifications – finished dietary supplement |
| Llorens Pharmaceuticals International Division, Inc. | Food and Cosmetics | 09/26/2025 | Component – verify identity, dietary ingredient |
| Llorens Pharmaceuticals International Division, Inc. | Food and Cosmetics | 09/26/2025 | Master manufacturing record – record requirements |
| Llorens Pharmaceuticals International Division, Inc. | Food and Cosmetics | 09/26/2025 | Criteria for establishing specifications |
| Llorens Pharmaceuticals International Division, Inc. | Food and Cosmetics | 09/26/2025 | Standard reference materials; criteria for selecting |
| Loco Chef | Food and Cosmetics | 05/26/2025 | Personnel |
| Loco Chef | Food and Cosmetics | 05/26/2025 | Plant construction and design |
| Loco Chef | Food and Cosmetics | 05/26/2025 | Pest control |
| Loco Chef | Food and Cosmetics | 05/26/2025 | Storage and Distribution |
| Lufran International Corporation | Food and Cosmetics | 12/16/2025 | Plant construction and design |
| Luis Felipe Covarrubias, LLC | Food and Cosmetics | 09/26/2025 | Qualifications of individuals |
| Luis Felipe Covarrubias, LLC | Food and Cosmetics | 09/26/2025 | Sanitation of food-contact surfaces – Frequency |
| Luis Felipe Covarrubias, LLC | Food and Cosmetics | 09/26/2025 | Sanitary facilities and controls |
| Luis Felipe Covarrubias, LLC | Food and Cosmetics | 09/26/2025 | Storage and Distribution |
| Luis Hernandez-Rosado, M.D. | Drugs | 08/12/2025 | FD-1572, protocol compliance |
| M & J All Solutions, LLC | Food and Cosmetics | 11/17/2025 | Specifications – components |
| M & J All Solutions, LLC | Food and Cosmetics | 11/17/2025 | Appropriate tests, examinations; certificate of analysis |
| M & J All Solutions, LLC | Food and Cosmetics | 11/17/2025 | Specifications met, in-process – quality finished batch |
| M & J All Solutions, LLC | Food and Cosmetics | 11/17/2025 | Specifications met – verify; finished batch |
| M & J All Solutions, LLC | Food and Cosmetics | 11/17/2025 | Examination, testing; scientifically valid |
| MEP Florida, LLC | Food and Cosmetics | 04/02/2025 | Sanitation monitoring |
| MEP Florida, LLC | Food and Cosmetics | 04/02/2025 | All hazards not considered |
| MEP Florida, LLC | Food and Cosmetics | 04/02/2025 | HACCP plan not implemented |
| MEP Florida, LLC | Food and Cosmetics | 04/02/2025 | Corrective action – predetermined plan |
| MEP Florida, LLC | Food and Cosmetics | 04/02/2025 | Verification activities – minimum |
| Macbrud Corporation | Devices | 05/21/2025 | Supplier oversight |
| Macbrud Corporation | Devices | 05/21/2025 | Lack of or inadequate procedures – Acceptance activities |
| Maria A. Carballosa, M.D. | Drugs | 03/06/2025 | Record retention |
| Mastergate, Inc. | Food and Cosmetics | 03/24/2025 | Hazard analysis written |
| Mastergate, Inc. | Food and Cosmetics | 03/24/2025 | Evaluation – performance, risk |
| Mastergate, Inc. | Food and Cosmetics | 03/24/2025 | Approved supplier procedures – importer established |
| Mastergate, Inc. | Food and Cosmetics | 03/24/2025 | Supplier verification – establish written procedures |
| Mastergate, Inc. | Food and Cosmetics | 03/24/2025 | Verification activity assurance |
| Medsite, Inc. | Food and Cosmetics | 05/14/2025 | Quality control operations – packaging, labeling; approving, rejecting |
| Medsite, Inc. | Food and Cosmetics | 05/14/2025 | Written procedures – establish; returned dietary supplements |
| Medsite, Inc. | Food and Cosmetics | 05/14/2025 | Written procedures – establish; product complaint |
| Menscience Androceuticals, LLC | Food and Cosmetics | 09/02/2025 | Written procedures – establish; returned dietary supplements |
| Menscience Androceuticals, LLC | Food and Cosmetics | 09/02/2025 | Written procedures – establish; product complaint |
| Mercagro, Corp. | Food and Cosmetics | 06/30/2025 | Document review entity’s hazard analysis |
| Mercagro, Corp. | Food and Cosmetics | 06/30/2025 | Evaluation – performance, risk |
| Miami Fruit, LLC | Food and Cosmetics | 03/10/2025 | Pest control |
| Miguel A. Mujica Baella, M.D. | Drugs | 02/20/2025 | Record retention |
| Mimmo’s Mozzarella | Food and Cosmetics | 11/05/2025 | Personnel |
| Mimmo’s Mozzarella | Food and Cosmetics | 11/05/2025 | Sanitary operations – Plant sanitation |
| Mimmo’s Mozzarella | Food and Cosmetics | 11/05/2025 | Manufacturing, processing, packing, holding – Controls |
| Moraima Trujillo, M.D. | Drugs | 12/18/2025 | FD-1572, protocol compliance |
| Moraima Trujillo, M.D. | Drugs | 12/18/2025 | Case history records- inadequate or inadequate |
| My Little Captain Gourmet, LLC | Food and Cosmetics | 08/08/2025 | Personnel |
| My Little Captain Gourmet, LLC | Food and Cosmetics | 08/08/2025 | Sanitary operations – Plant sanitation |
| My Little Captain Gourmet, LLC | Food and Cosmetics | 08/08/2025 | Manufacturing, processing, packing, holding – Controls |
| My Little Captain Gourmet, LLC | Food and Cosmetics | 08/08/2025 | Food safety plan |
| NPR Enterprises, Inc. | Food and Cosmetics | 08/22/2025 | Develop FSVP |
| Naked Whey, Inc. | Food and Cosmetics | 04/24/2025 | Develop FSVP |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Specifications – components |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Specifications – finished dietary supplement |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Component – certificate of analysis |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Specifications met, in-process – quality finished batch |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Master manufacturing record – record requirements |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Batch record – follow master |
| Natural Genesis Lab, LLC | Food and Cosmetics | 11/03/2025 | Written procedures – follow; holding and distribution |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Personnel |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Plant construction and design |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Sanitary operations – Plant sanitation |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Pest control |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Sanitation of food-contact surfaces – Frequency |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Equipment and utensils – Design and maintenance |
| New York Bakeries, Inc. | Food and Cosmetics | 05/27/2025 | Manufacturing, processing, packing, holding – Controls |
| Noatum Logistics USA, LLC | Food and Cosmetics | 05/15/2025 | Pest control |
| Novutech, LLC | Biologics | 02/06/2025 | Storage temperatures recorded, maintained |
| Novutech, LLC | Biologics | 02/06/2025 | Procedures and release criteria |
| Novutech, LLC | Biologics | 02/06/2025 | Return to inventory–procedures |
| Novutech, LLC | Biologics | 02/06/2025 | HCT/Ps not tracked |
| Novutech, LLC | Biologics | 02/06/2025 | Procedures re complaints |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Instruments – calibration |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Production, process controls – implement |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Component – verify identity, dietary ingredient |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Written procedures – establish; quality control operations |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Batch record – every batch |
| Nutraceutic Labs, Inc. | Food and Cosmetics | 10/30/2025 | Written procedures – establish; product complaint |
| Ocean Biz, LLC | Food and Cosmetics | 05/22/2025 | Importer verification |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 02/12/2025 | Hazard analysis |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 02/12/2025 | HACCP plan implementation |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 02/12/2025 | Food safety hazards |
| Ocho Rios-Miami, Inc. | Food and Cosmetics | 02/12/2025 | Verification – record review – frequency |
| Orion Global Holdings, LLC | Food and Cosmetics | 12/23/2025 | Develop FSVP |
| Orizon Foods, LLC | Food and Cosmetics | 03/13/2025 | Develop FSVP |
| P & D Pharmaint, Inc. | Food and Cosmetics | 09/26/2025 | Written procedures – establish; returned dietary supplements |
| P & D Pharmaint, Inc. | Food and Cosmetics | 09/26/2025 | Written procedures – establish; product complaint |
| PE Packaging, LLC | Drugs | 08/01/2025 | Procedures not in writing, fully followed |
| PE Packaging, LLC | Drugs | 08/01/2025 | Defined areas of adequate size for operations |
| PE Packaging, LLC | Drugs | 08/01/2025 | Equipment Design, Size and Location |
| PE Packaging, LLC | Drugs | 08/01/2025 | Absence of Written Procedures |
| PE Packaging, LLC | Drugs | 08/01/2025 | Storage under appropriate conditions |
| PIZZACINI, Corp. | Food and Cosmetics | 11/19/2025 | Personnel |
| PIZZACINI, Corp. | Food and Cosmetics | 11/19/2025 | Cleaning and sanitizing substances – Safe and adequate |
| PIZZACINI, Corp. | Food and Cosmetics | 11/19/2025 | Sanitation of food-contact surfaces – Frequency |
| PRG Management, LLC | Devices | 02/14/2025 | Documented evaluation |
| PRG Management, LLC | Devices | 02/14/2025 | Lack of or inadequate receiving acceptance procedures |
| PRG Management, LLC | Devices | 02/14/2025 | Lack of or inadequate complaint procedures |
| PTP Produce, LLC | Food and Cosmetics | 04/24/2025 | Develop FSVP |
| Packset Corporation | Food and Cosmetics | 03/04/2025 | Develop FSVP |
| Packset Corporation | Food and Cosmetics | 11/05/2025 | Develop FSVP |
| Park Street Imports, LLC | Food and Cosmetics | 03/04/2025 | Hazard analysis biological, chemical, physical |
| Park Street Imports, LLC | Food and Cosmetics | 03/04/2025 | Document review entity’s hazard analysis |
| Park Street Imports, LLC | Food and Cosmetics | 03/04/2025 | Evaluation – performance, risk |
| Park Street Imports, LLC | Food and Cosmetics | 03/04/2025 | Reevaluate – 3 years |
| Park Street Imports, LLC | Food and Cosmetics | 03/04/2025 | Approved supplier procedures – importer established |
| Patagonia Distribution, LLC | Food and Cosmetics | 08/18/2025 | No HACCP plan |
| Patagonia Distribution, LLC | Food and Cosmetics | 08/18/2025 | Calibration – adequacy |
| Patagonia Distribution, LLC | Food and Cosmetics | 08/18/2025 | HACCP training or qualification |
| Patagonia Distribution, LLC | Food and Cosmetics | 08/18/2025 | Sanitation monitoring |
| Patagonia Distribution, LLC | Food and Cosmetics | 08/18/2025 | Importer verification |
| Patagonia Processing USA, Inc. | Food and Cosmetics | 07/02/2025 | Signed and dated |
| Patagonia Processing USA, Inc. | Food and Cosmetics | 07/02/2025 | Sanitation monitoring documentation |
| Pescanova, Inc. | Food and Cosmetics | 06/12/2025 | Importer verification |
| Petruz Fruity, LLC | Food and Cosmetics | 08/22/2025 | Hazard analysis written |
| Petruz Fruity, LLC | Food and Cosmetics | 08/22/2025 | Disclosure – customer subject cGMP |
| Petruz Fruity, LLC | Food and Cosmetics | 08/22/2025 | Assurance – customer controls hazard CGMPs |
| Petruz Fruity, LLC | Food and Cosmetics | 08/22/2025 | Identification – entry |
| Port Royale Trading Company, Inc. | Food and Cosmetics | 08/19/2025 | Food safety hazards |
| Port Royale Trading Company, Inc. | Food and Cosmetics | 08/19/2025 | Monitoring – adequacy |
| Port Royale Trading Company, Inc. | Food and Cosmetics | 08/19/2025 | Corrective action plan |
| Port Royale Trading Company, Inc. | Food and Cosmetics | 08/19/2025 | Sanitation monitoring documentation |
| ProSolus, Inc. | Drugs | 07/25/2025 | Procedures not in writing, fully followed |
| ProSolus, Inc. | Drugs | 07/25/2025 | Absence of Written Procedures |
| ProSolus, Inc. | Drugs | 07/25/2025 | Review of representative number of batches |
| Purchase Order Of Miami | Food and Cosmetics | 02/26/2025 | Storage and Distribution |
| Rabbex, LLC | Food and Cosmetics | 10/23/2025 | Hazard analysis – Identification of hazard |
| Rabbex, LLC | Food and Cosmetics | 10/23/2025 | Process preventive controls – Appropriate (Adequate) |
| Randall Bakery Corporation | Food and Cosmetics | 10/31/2025 | Personnel |
| Randall Bakery Corporation | Food and Cosmetics | 10/31/2025 | Sanitary operations – Plant sanitation |
| Randall Bakery Corporation | Food and Cosmetics | 10/31/2025 | Storage and Distribution |
| Randall Bakery Corporation | Food and Cosmetics | 10/31/2025 | Modified requirement: Temperature control – Implement |
| Rayi, LLC | Food and Cosmetics | 03/27/2025 | Develop FSVP |
| Rayi, LLC | Food and Cosmetics | 10/29/2025 | Document review entity’s hazard analysis |
| Rayi, LLC | Food and Cosmetics | 10/29/2025 | Supplier approval – document |
| Rayi, LLC | Food and Cosmetics | 10/29/2025 | Approved supplier procedures – importer established |
| Rayi, LLC | Food and Cosmetics | 10/29/2025 | Supplier verification – establish written procedures |
| Rey Chavez Distributor Corporation | Food and Cosmetics | 10/02/2025 | Sanitation Records |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Qualifications of individuals |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Personnel |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Sanitary operations – Plant maintenance |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Sanitary operations – Plant sanitation |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Pest control |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Sanitation of food-contact surfaces – Frequency |
| Rika Bakeries, Inc. | Food and Cosmetics | 06/30/2025 | Manufacturing, processing, packing, holding – Controls |
| Rnv, LLC | Drugs | 10/31/2025 | SOPs not followed / documented |
| Rnv, LLC | Drugs | 10/31/2025 | Identification of containers, lines, equipment |
| Rnv, LLC | Drugs | 10/31/2025 | Investigations of discrepancies, failures |
| Robert G. Perry, M.D. | Drugs | 09/05/2025 | FD-1572, protocol compliance |
| Rossbach International Florida, Inc. | Food and Cosmetics | 07/08/2025 | Develop FSVP |
| Rudel Enterprises, Inc. | Food and Cosmetics | 10/22/2025 | Hazard analysis – Identification of hazard |
| Rudel Enterprises, Inc. | Food and Cosmetics | 10/22/2025 | Process preventive controls – Appropriate (Adequate) |
| Sabor Bendito, LLC | Food and Cosmetics | 06/02/2025 | Personnel |
| Sabor Bendito, LLC | Food and Cosmetics | 06/02/2025 | Sanitary operations – Plant sanitation |
| Sabor Bendito, LLC | Food and Cosmetics | 06/02/2025 | Manufacturing, processing, packing, holding – Controls |
| Sazon, Inc. | Food and Cosmetics | 11/18/2025 | Hazard analysis – Identification of hazard |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Make and keep records – equipment and utensils |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Specifications – components |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Specifications – labels, packaging |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Specifications – finished dietary supplement |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Written procedures – establish; quality control operations |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Records – material review, follow-up |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Master manufacturing record – prepared |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Batch record – every batch |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Batch record – required information |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Records – written procedures holding and distribution; product distribution |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Make and keep records – returned dietary supplements |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Records – written procedures; product complaint |
| Scarleth Research, LLC | Food and Cosmetics | 04/22/2025 | Scheduled process establishment |
| Sea Arts, LLC | Food and Cosmetics | 05/15/2025 | Importer verification |
| Seven Stars Popsicles of America, LLC | Food and Cosmetics | 10/29/2025 | Personnel |
| Seven Stars Popsicles of America, LLC | Food and Cosmetics | 10/29/2025 | Sanitary operations – Plant sanitation |
| Seven Stars Popsicles of America, LLC | Food and Cosmetics | 10/29/2025 | Toxic chemicals – Identified, held, stored |
| Seven Stars Popsicles of America, LLC | Food and Cosmetics | 10/29/2025 | Equipment and utensils – Design and maintenance |
| Seven Stars Popsicles of America, LLC | Food and Cosmetics | 10/29/2025 | Manufacturing, processing, packing, holding – Controls |
| Signature Foods, Inc. | Food and Cosmetics | 07/11/2025 | Personnel |
| Signature Foods, Inc. | Food and Cosmetics | 07/11/2025 | Food safety plan |
| Silq Technologies Corporation | Devices | 10/16/2025 | Individual Report of Malfunction |
| Silq Technologies Corporation | Devices | 10/16/2025 | Design changes – Lack of or Inadequate Procedures |
| Solara, Inc. | Food and Cosmetics | 09/17/2025 | Specifications met – verify; finished batch |
| Solara, Inc. | Food and Cosmetics | 09/17/2025 | Quality control operations – specifications; components, packaging, labels |
| Solara, Inc. | Food and Cosmetics | 09/17/2025 | Master manufacturing record – record requirements |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Personnel |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Plant construction and design |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Pest control |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Sanitation of food-contact surfaces – Frequency |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Hazard analysis – Identification of hazard |
| South Florida Bakery, Inc. | Food and Cosmetics | 06/24/2025 | Sanitation preventive controls – Implement |
| St. James Smokehouse, Inc. | Food and Cosmetics | 10/08/2025 | Food safety hazards |
| St. James Smokehouse, Inc. | Food and Cosmetics | 10/08/2025 | Critical limits |
| St. James Smokehouse, Inc. | Food and Cosmetics | 10/08/2025 | Sanitation monitoring documentation |
| Stat Medical Devices, Inc. | Devices | 03/18/2025 | Label to bear a unique device identifier |
| Stat Medical Devices, Inc. | Devices | 03/18/2025 | Training records |
| Stat Medical Devices, Inc. | Devices | 03/18/2025 | Design control – no procedures |
| Stat Medical Devices, Inc. | Devices | 03/18/2025 | Nonconforming product, Lack of or inadequate procedures |
| Sucden Americas Corporation | Food and Cosmetics | 03/31/2025 | Hazard analysis biological, chemical, physical |
| Sucden Americas Corporation | Food and Cosmetics | 03/31/2025 | Supplier verification – establish written procedures |
| Sucden Americas Corporation | Food and Cosmetics | 03/31/2025 | Verification activity frequency |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Develop FSVP |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Hazard analysis written |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Evaluation – performance, risk |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Approved supplier procedures – importer established |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Supplier verification – establish written procedures |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Verification activity frequency |
| Sula Food and Beverage Corporation | Food and Cosmetics | 08/22/2025 | Record – translate to English |
| Sumsum FL, LLC | Food and Cosmetics | 11/17/2025 | Personnel |
| Sumsum FL, LLC | Food and Cosmetics | 11/17/2025 | Sanitary operations – Plant sanitation |
| Sunlight Foods | Food and Cosmetics | 03/14/2025 | Develop FSVP |
| Super Fish Seafood Corporation | Food and Cosmetics | 07/22/2025 | Importer verification |
| Supercan Bully Sticks, LLC | Veterinary | 05/22/2025 | Food Safety Plan |
| Supercan Bully Sticks, LLC | Veterinary | 04/23/2025 | Develop FSVP |
| Surf Snax, Inc., Ltd. | Veterinary | 10/24/2025 | Personnel |
| Surf Snax, Inc., Ltd. | Veterinary | 10/24/2025 | Plant Maintenance |
| Surf Snax, Inc., Ltd. | Veterinary | 10/24/2025 | Animal Food Contact Surfaces |
| Surf Snax, Inc., Ltd. | Veterinary | 10/24/2025 | Plant Operations |
| Surf Snax, Inc., Ltd. | Veterinary | 10/24/2025 | Raw Material Controls |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Label to bear a unique device identifier |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Lack of System for Event Evaluations |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Management review – defined interval, sufficient frequency |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Quality Audits – defined intervals |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Evaluation of suppliers, contractors, etc., requirements |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Contamination control, Lack of or inadequate procedures |
| Tarmac Products, Inc. | Devices | 11/04/2025 | Devices subject to device identification GUDID data submission requirements. |
| Terra Austral South America, LLC | Food and Cosmetics | 12/04/2025 | Importer verification |
| Tierra Suelta, Inc. | Food and Cosmetics | 03/20/2025 | Develop FSVP |
| Time Two Grow, LLC | Food and Cosmetics | 04/04/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Time Two Grow, LLC | Food and Cosmetics | 04/04/2025 | Plant operations – Precautions |
| Time Two Grow, LLC | Food and Cosmetics | 04/04/2025 | Appropriate quality control operations |
| Time Two Grow, LLC | Food and Cosmetics | 04/04/2025 | Manufacturing, processing, packing, holding – Controls |
| Tipical Latin Foods | Food and Cosmetics | 05/19/2025 | Personnel |
| Tipical Latin Foods | Food and Cosmetics | 05/19/2025 | Sanitary operations – Plant sanitation |
| Tipical Latin Foods | Food and Cosmetics | 05/19/2025 | Equipment and utensils – Design and maintenance |
| Tipical Latin Foods | Food and Cosmetics | 05/19/2025 | Storage and Distribution |
| Tipical Latin Foods | Food and Cosmetics | 05/19/2025 | Hazard analysis – Identification of hazard |
| Toby Orthopaedics, Inc. | Devices | 07/15/2025 | Management review – defined interval, sufficient frequency |
| Toby Orthopaedics, Inc. | Devices | 07/15/2025 | Quality Audits – defined intervals |
| Toby Orthopaedics, Inc. | Devices | 07/15/2025 | Design validation – documentation |
| Tocumen Produce, Inc. | Food and Cosmetics | 04/25/2025 | Qualified individual FSVP activities |
| Tocumen Produce, Inc. | Food and Cosmetics | 04/25/2025 | Hazard analysis written |
| Tocumen Produce, Inc. | Food and Cosmetics | 04/25/2025 | Evaluation – performance, risk |
| Tocumen Produce, Inc. | Food and Cosmetics | 04/25/2025 | Supplier verification – follow written procedures |
| Traditional Snack, Inc. | Food and Cosmetics | 07/29/2025 | Personnel |
| Traditional Snack, Inc. | Food and Cosmetics | 07/29/2025 | Toxic chemicals – Identified, held, stored |
| Traditional Snack, Inc. | Food and Cosmetics | 07/29/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Traditional Snack, Inc. | Food and Cosmetics | 07/29/2025 | Equipment and utensils – Design and maintenance |
| Traditional Snack, Inc. | Food and Cosmetics | 07/29/2025 | Manufacturing, processing, packing, holding – Controls |
| Tropical Cheese Industries | Food and Cosmetics | 12/19/2025 | Sanitation monitoring |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Plant construction and design |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Equipment and utensils – Design and maintenance |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Plant operations – Precautions |
| Tropical Key, Inc. | Food and Cosmetics | 05/08/2025 | Manufacturing, processing, packing, holding – Controls |
| Tropical World Corporation | Food and Cosmetics | 08/22/2025 | Record – translate to English |
| Trujillo Oil | Food and Cosmetics | 06/26/2025 | Sanitation monitoring |
| Trujillo Oil | Food and Cosmetics | 06/26/2025 | HACCP plan – critical limits not listed or not adequate |
| Txapela | Food and Cosmetics | 04/07/2025 | Plant construction and design |
| Ultra Trading International, Ltd. | Food and Cosmetics | 01/08/2025 | Revaluate – new information |
| Ultra Trading International, Ltd. | Food and Cosmetics | 01/08/2025 | Reevaluate – document |
| Ultra Trading International, Ltd. | Food and Cosmetics | 01/08/2025 | Sampling, testing |
| Umay Trade Company, LLC | Veterinary | 03/07/2025 | Approved supplier procedures – importer established |
| Umay Trade Company, LLC | Veterinary | 03/07/2025 | Verification activity before import, periodically |
| Valley Food Produce, Inc. | Food and Cosmetics | 04/15/2025 | Develop FSVP |
| Valmar Group, LLC | Food and Cosmetics | 02/24/2025 | HACCP plan implementation |
| Valmar Group, LLC | Food and Cosmetics | 02/24/2025 | HACCP plan location |
| Valmar Group, LLC | Food and Cosmetics | 02/24/2025 | Signed and dated |
| Valmar Group, LLC | Food and Cosmetics | 02/24/2025 | Sanitation monitoring |
| Valmar Group, LLC | Food and Cosmetics | 02/24/2025 | Importer verification |
| Victoria Bakery and Restaurant, Corp. | Food and Cosmetics | 12/08/2025 | Sanitary operations – Plant sanitation |
| Victoria Bakery and Restaurant, Corp. | Food and Cosmetics | 12/08/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Virgina Louis Duplessis | Food and Cosmetics | 06/26/2025 | Develop FSVP |
| Wild Animals Brewing, LLC | Food and Cosmetics | 10/14/2025 | Pest control |
| World Perfumes, Inc. | Drugs | 05/09/2025 | Procedures not in writing, fully followed |
| World Perfumes, Inc. | Drugs | 05/09/2025 | Sanitation–buildings not clean, free of infestation |
| World Perfumes, Inc. | Drugs | 05/09/2025 | Procedures To Be in Writing |
| World Perfumes, Inc. | Drugs | 05/09/2025 | Handling and Storage to Prevent Contamination |
| World Wise Consulting, Inc. | Food and Cosmetics | 08/28/2025 | Develop FSVP |
| World Wise Consulting, Inc. | Veterinary | 08/28/2025 | Develop FSVP |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Approve or reject components, products |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Buildings not maintained in good state of repair |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Identity Testing of Each Component |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Absence of Written Procedures |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Strict control not exercised over labeling issued |
| Xtreme Tools International, Inc. | Drugs | 01/31/2025 | Scientifically sound laboratory controls |
| Yes Fresh, Inc. | Food and Cosmetics | 12/18/2025 | Supplier verification – establish written procedures |
| Yes Fresh, Inc. | Food and Cosmetics | 12/18/2025 | Verification activity before import, periodically |
| Yes Fresh, Inc. | Food and Cosmetics | 12/18/2025 | Identification – entry |
| YummmyCo, Inc. | Food and Cosmetics | 03/19/2025 | Personnel |
| YummmyCo, Inc. | Food and Cosmetics | 03/19/2025 | Plant construction and design |
| YummmyCo, Inc. | Food and Cosmetics | 03/19/2025 | Sanitary operations – Plant maintenance |
| YummmyCo, Inc. | Food and Cosmetics | 03/19/2025 | Pest control |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
