How many companies in cities across Miami-Dade County received FDA citations in 2024?

How many companies in cities across Miami-Dade County received FDA citations in 2024?
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA — Official Website
0Comments

There were 68 companies in cities associated with Miami-Dade County that received FDA citations as a result of 68 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 39.3% decrease from the number of companies cited in the previous year.

Of the 216 citations issued, the most common citations were ‘You did not take a reasonable measure or precaution related to personnel practices’ and ‘You did not have a written food safety plan’.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Devices sector.

Of the companies cited, 63 should take voluntary actions to correct their managing operations (92.6%). Additionally, five companies had to take regulatory and/or administrative actions (7.4%).

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 quality.

Companies Located Within Miami-Dade County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
305 Pizza at Mia, LLC Food and Cosmetics 07/17/2024 Sanitary operations – Plant sanitation
305 Pizza at Mia, LLC Food and Cosmetics 07/17/2024 Sanitary facilities and controls
305 Pizza at Mia, LLC Food and Cosmetics 07/17/2024 Food safety plan
ALK Trading, Corp. Food and Cosmetics 01/09/2024 Develop FSVP
Advanced Instrumentations, Inc. Devices 02/26/2024 Design history file
Advanced Instrumentations, Inc. Devices 02/26/2024 Procedures not adequately established or maintained
Advanced Instrumentations, Inc. Devices 02/26/2024 Purchasing controls, Lack of or inadequate procedures
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Cleaning compounds and toxic materials – holding
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Hand-washing facilities
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Specifications-component purity, strength, composition
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Specifications – identity, purity, strength, composition
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Master manufacturing record – each batch
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Packaging description, representative label
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Written procedures – laboratory operations
Alfa Vitamins Laboratories, Inc. Food and Cosmetics 07/17/2024 Hold – temperature, humidity, light
Americo F. Padilla, M.D. Drugs 02/16/2024 Documentation of permission by parents or guardian
Americo F. Padilla, M.D. Drugs 02/16/2024 FD-1572, protocol compliance
Americo F. Padilla, M.D. Drugs 02/16/2024 Case history records- inadequate or inadequate
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Hand-washing facilities
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Equipment – maintain, clean, sanitize
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Specifications – component identity
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Specifications-component purity, strength, composition
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Specifications met – verify; finished batch
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Written procedures – quality control operations
Aqua Nutraceuticals, LLC Food and Cosmetics 06/25/2024 Dietary supplement – protect, contamination
BioTissue Holdings, Inc. Devices 03/06/2024 Report of Death or Serious Injury
BioTissue Holdings, Inc. Devices 03/06/2024 Individual Report of Malfunction
BioTissue Holdings, Inc. Devices 03/06/2024 Documentation
BioTissue Holdings, Inc. Devices 03/06/2024 Investigation of device failures
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Personnel
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Sanitary operations – Plant sanitation
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Toxic chemicals – Identified, held, stored
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Pest control
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Sanitary facilities and controls
Charanga Catering, LLC Food and Cosmetics 03/06/2024 Manufacturing, processing, packing, holding – Controls
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Develop FSVP
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Document review entity’s hazard analysis
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Evaluation – performance, risk
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Approved supplier procedures – importer established
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Supplier verification – establish written procedures
Cherry Glass USA, Inc. Food and Cosmetics 04/26/2024 Record – translate to English
Cubanita Frozen Foods Corporation Food and Cosmetics 07/12/2024 Personnel
Cubanita Frozen Foods Corporation Food and Cosmetics 07/12/2024 Pest control
Cubanita Frozen Foods Corporation Food and Cosmetics 07/12/2024 Manufacturing, processing, packing, holding – Controls
Cubanita Frozen Foods Corporation Food and Cosmetics 07/12/2024 Food safety plan
Custom Manufacturing Corporation Veterinary 01/11/2024 Procedures not in writing, fully followed
Custom Manufacturing Corporation Veterinary 01/11/2024 Defined areas of adequate size for operations
Custom Manufacturing Corporation Veterinary 01/11/2024 Buildings not maintained in good state of repair
Custom Manufacturing Corporation Veterinary 01/11/2024 Identity Testing of Each Component
Custom Manufacturing Corporation Veterinary 01/11/2024 Absence of Written Procedures
Custom Manufacturing Corporation Veterinary 01/11/2024 Testing and release for distribution
Custom Manufacturing Corporation Veterinary 01/11/2024 Lack of written stability program
DC Production Food and Cosmetics 06/24/2024 Personnel
DC Production Food and Cosmetics 06/24/2024 Food safety plan
David’s Tower US Food and Cosmetics 06/21/2024 Plant construction and design
David’s Tower US Food and Cosmetics 06/21/2024 Modified requirement: Temperature control – Implement
Deka Trading Corporation Food and Cosmetics 12/18/2024 Plant construction and design
Deka Trading Corporation Food and Cosmetics 12/18/2024 Pest control
Dextrum Laboratories, Inc. Drugs 08/29/2024 Procedures not in writing, fully followed
Dextrum Laboratories, Inc. Drugs 08/29/2024 Equipment Design, Size and Location
Dextrum Laboratories, Inc. Drugs 08/29/2024 Component written specification
Dextrum Laboratories, Inc. Drugs 08/29/2024 Written in-process control procedures
Dextrum Laboratories, Inc. Drugs 08/29/2024 Procedures for sterile drug products
Dextrum Laboratories, Inc. Drugs 08/29/2024 Written program not followed
Dharma Research, Inc. Devices 12/11/2024 Design validation – documentation
Dharma Research, Inc. Devices 12/11/2024 Documentation
Dharma Research, Inc. Devices 12/11/2024 DHR content
Dr. Desserts, Inc. Food and Cosmetics 12/23/2024 Personnel
Dr. Desserts, Inc. Food and Cosmetics 12/23/2024 Sanitary operations – Plant maintenance
Dr. Desserts, Inc. Food and Cosmetics 12/23/2024 Sanitary operations – Plant sanitation
Dr. Desserts, Inc. Food and Cosmetics 12/23/2024 Cleaning and sanitizing substances – Safe and adequate
EUSA Global, LLC Devices 03/22/2024 Management review – defined interval, sufficient frequency
EUSA Global, LLC Devices 03/22/2024 Nonconforming product, Lack of or inadequate procedures
EUSA Global, LLC Devices 03/22/2024 Lack of or inadequate procedures for labeling
EUSA Global, LLC Devices 03/22/2024 Lack of or inadequate complaint procedures
Edda’s Cake Company Food and Cosmetics 02/05/2024 Personnel
Edda’s Cake Company Food and Cosmetics 02/05/2024 Food safety plan
Efficient Laboratories, Inc. Food and Cosmetics 04/25/2024 Specifications met – quality
Efficient Laboratories, Inc. Food and Cosmetics 04/25/2024 Written procedures – quality control operations
Efficient Laboratories, Inc. Food and Cosmetics 04/25/2024 Quality control – supplier qualification
Efficient Laboratories, Inc. Food and Cosmetics 04/25/2024 Quality control – batch, product specifications
Efficient Laboratories, Inc. Food and Cosmetics 04/25/2024 Quality control – processes, specifications, written procedures
El Faro Bakery, Inc. Food and Cosmetics 06/28/2024 Hazard analysis – Identification of hazard
Filthy Food, LLC Food and Cosmetics 04/01/2024 Process filing
Filthy Food, LLC Food and Cosmetics 04/01/2024 Quality control procedures
Filthy Food, LLC Food and Cosmetics 04/01/2024 Code – required elements
Filthy Food, LLC Food and Cosmetics 04/01/2024 Scheduled process establishment
GC Food Factory, LLC Food and Cosmetics 03/22/2024 Food safety plan
Gables Produce, LLC Food and Cosmetics 05/01/2024 Develop FSVP
Gonzalez and Nietos, LLC Food and Cosmetics 12/16/2024 Storage and Distribution
Gonzalez and Nietos, LLC Food and Cosmetics 12/16/2024 Sanitation monitoring
Gonzalez and Nietos, LLC Food and Cosmetics 12/16/2024 Importer verification
Greater Miami Caterers, Inc. Food and Cosmetics 06/28/2024 Pest control
Greater Miami Caterers, Inc. Food and Cosmetics 06/28/2024 Equipment and utensils – Design and maintenance
Greater Miami Caterers, Inc. Food and Cosmetics 06/28/2024 Manufacturing, processing, packing, holding – Controls
Greater Miami Caterers, Inc. Food and Cosmetics 06/28/2024 Food safety plan
Guenther Koehne, M.D. Drugs 01/10/2024 FD-1572, protocol compliance
Herbalife International Corporation Food and Cosmetics 04/16/2024 Written procedures – holding
ILS Group, LLC Food and Cosmetics 06/17/2024 Food safety plan
Innovative Transfusion Medicine, Inc. Biologics 10/07/2024 Establish, maintain and follow manufacturing SOPs
Innovative Transfusion Medicine, Inc. Biologics 10/07/2024 Required records
Innovative Transfusion Medicine, Inc. Biologics 10/07/2024 Review Records to ID Previous Donations [Collecting Estab]
Innovative Transfusion Medicine, Inc. Biologics 10/07/2024 Review Records ID Previous Donations [Collecting Estab]
Interfood Trading Group, Inc. Food and Cosmetics 07/09/2024 Develop FSVP
Interfood Trading Group, Inc. Food and Cosmetics 07/09/2024 Record – available
Island Dairy, LLC Food and Cosmetics 04/05/2024 Pest control
Island Dairy, LLC Food and Cosmetics 04/05/2024 Manufacturing, processing, packing, holding – Controls
Jackson Memorial Hospital Transfusion Medicine Services Biologics 12/17/2024 Equipment observed, standardized, calibrated
Jackson Memorial Hospital Transfusion Medicine Services Biologics 12/17/2024 Concurrent documentation
Kapi Kapi Growers, Inc. Food and Cosmetics 02/01/2024 Develop FSVP
LEASA Industries Company, Inc. Food and Cosmetics 07/26/2024 Equip & tools – cleanability
LEASA Industries Company, Inc. Food and Cosmetics 07/26/2024 Written environmental monitoring plan
La Crocante Fine Foods Distributor, LLC Food and Cosmetics 05/24/2024 Food safety plan
Lan Industries, LLC Food and Cosmetics 01/31/2024 Specifications – contamination limits
Lan Industries, LLC Food and Cosmetics 01/31/2024 Component – verify identity, dietary ingredient
Lan Industries, LLC Food and Cosmetics 01/31/2024 Packaging description, representative label
Lan Industries, LLC Food and Cosmetics 01/31/2024 Identifying, holding – contamination, mix-ups
Lan Industries, LLC Food and Cosmetics 01/31/2024 Quality control operations – master manufacturing record, modifications
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Personnel
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Sanitary operations – Plant maintenance
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Pest control
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Sanitation of food-contact surfaces – Frequency
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Equipment and utensils – Design and maintenance
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Raw materials and rework controls – Filth and contamination
Latin Flavors Enterprises, Inc. Food and Cosmetics 12/18/2024 Food safety plan
Legend Aerospace, Inc. Devices 05/01/2024 Lack of Written MDR Procedures
Legend Aerospace, Inc. Devices 05/01/2024 Purchasing controls, Lack of or inadequate procedures
Legend Aerospace, Inc. Devices 05/01/2024 Complaints
Leon Holdings of Miami, LLC Food and Cosmetics 08/02/2024 Develop FSVP
Lila’s Desserts, Inc. Food and Cosmetics 09/10/2024 Process preventive controls – Implement
Lila’s Desserts, Inc. Food and Cosmetics 09/10/2024 Supply-chain program – Assurance (Adequate)
Medas, Inc. Devices 04/26/2024 Procedures not adequately established or maintained
Medas, Inc. Devices 04/26/2024 Lack of or inadequate procedures
Medas, Inc. Devices 04/26/2024 Lack of or inadequate procedures for storage.
Medas, Inc. Devices 04/26/2024 Lack of or inadequate complaint procedures
Medipharm Laboratories, Inc. Drugs 02/23/2024 Procedures not in writing, fully followed
Medipharm Laboratories, Inc. Drugs 02/23/2024 Training–operations, GMPs, written procedures
Misha’s Cupcakes, Inc. Food and Cosmetics 02/28/2024 Personnel
Misha’s Cupcakes, Inc. Food and Cosmetics 02/28/2024 Pest control
Misha’s Cupcakes, Inc. Food and Cosmetics 02/28/2024 Sanitation of non-food-contact surfaces – Manner and frequency
Multi Global Products USA, Inc. Food and Cosmetics 05/14/2024 Develop FSVP
Multi Global Products USA, Inc. Food and Cosmetics 05/14/2024 Hazard analysis biological, chemical, physical
Multi Global Products USA, Inc. Food and Cosmetics 05/14/2024 Verification activity frequency
Multi Global Products USA, Inc. Food and Cosmetics 05/14/2024 Verification activity before import, periodically
Naturavit, Inc. Food and Cosmetics 05/31/2024 Specifications – identity, purity, strength, composition
Naturavit, Inc. Food and Cosmetics 05/31/2024 Appropriate tests, examinations; certificate of analysis
Naturavit, Inc. Food and Cosmetics 05/31/2024 Written procedures – quality control operations
Naturavit, Inc. Food and Cosmetics 05/31/2024 Written procedures – labeling operations
Neocis, Inc. Devices 06/28/2024 Individual Report of Malfunction
Neocis, Inc. Devices 06/28/2024 Date Received by Manufacturer
Newpharma, Inc. Food and Cosmetics 07/01/2024 Quality control – production, process control
Newpharma, Inc. Food and Cosmetics 07/01/2024 Quality control – reject; specification not met
Newpharma, Inc. Food and Cosmetics 07/01/2024 Written procedures – packaging
Obem Foods, Inc. Food and Cosmetics 06/24/2024 Personnel
Ocho Rios-Miami, Inc. Food and Cosmetics 07/16/2024 Hazard analysis
Ocho Rios-Miami, Inc. Food and Cosmetics 07/16/2024 HACCP plan implementation
Ocho Rios-Miami, Inc. Food and Cosmetics 07/16/2024 Food safety hazards
Ocho Rios-Miami, Inc. Food and Cosmetics 07/16/2024 Verification – record review – frequency
Olga M. Lapeyra, M.D. Drugs 06/07/2024 FD-1572, protocol compliance
Pacific Seafood Miami Food and Cosmetics 07/03/2024 Food safety hazards
Pacific Seafood Miami Food and Cosmetics 07/03/2024 Sanitation monitoring
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Instruments – calibration
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Make and keep records – equipment and utensils
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Specifications – components
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Specifications – labels, packaging
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Specifications – finished dietary supplement
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Component – verify identity, dietary ingredient
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Specifications met – verify; finished batch
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Documentation – requirements
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Master manufacturing record – prepared
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Master manufacturing record – record requirements
Perez Lab, Inc. Food and Cosmetics 09/06/2024 Batch record – required information
Polaroma, LLC Food and Cosmetics 08/15/2024 Plant construction and design
SensiMedical, LLC Devices 01/19/2024 Design history file
Skeletal Dynamics, Inc. Devices 04/05/2024 Not approved or obsolete document retrieval
Skeletal Dynamics, Inc. Devices 04/05/2024 Purchasing controls, Lack of or inadequate procedures
Skeletal Dynamics, Inc. Devices 04/05/2024 Maintenance schedule, Lack of or inadequate schedule
Skeletal Dynamics, Inc. Devices 04/05/2024 Lack of or inadequate receiving acceptance procedures
Skeletal Dynamics, Inc. Devices 04/05/2024 Lack of or inadequate DHR procedures
Speedbolea, LLC Food and Cosmetics 08/21/2024 Plant construction and design
Speedbolea, LLC Food and Cosmetics 08/21/2024 Sanitary operations – Plant sanitation
Speedbolea, LLC Food and Cosmetics 08/21/2024 Equipment and utensils – Design and maintenance
Speedbolea, LLC Food and Cosmetics 08/21/2024 Plant operations – Precautions
Speedbolea, LLC Food and Cosmetics 08/21/2024 Manufacturing, processing, packing, holding – Controls
Star Bakery, Inc. Food and Cosmetics 12/05/2024 Personnel
Star Bakery, Inc. Food and Cosmetics 12/05/2024 Grounds
Star Bakery, Inc. Food and Cosmetics 12/05/2024 Plant construction and design
Star Bakery, Inc. Food and Cosmetics 12/05/2024 Sanitary operations – Plant maintenance
Steven E. Chavoustie, M.D. Drugs 09/25/2024 FD-1572, protocol compliance
Steven E. Chavoustie, M.D. Drugs 09/25/2024 Accountability records
TTS Food, LLC Food and Cosmetics 08/02/2024 Plant construction and design
TTS Food, LLC Food and Cosmetics 08/02/2024 Toxic chemicals – Identified, held, stored
TTS Food, LLC Food and Cosmetics 08/02/2024 Equipment and utensils – Design and maintenance
TTS Food, LLC Food and Cosmetics 08/02/2024 Plant operations – Precautions
Tipical Latin Food, Corporation Food and Cosmetics 12/23/2024 Personnel
Tipical Latin Food, Corporation Food and Cosmetics 12/23/2024 Sanitary operations – Plant sanitation
Tipical Latin Food, Corporation Food and Cosmetics 12/23/2024 Pest control
Tipical Latin Food, Corporation Food and Cosmetics 12/23/2024 Equipment and utensils – Design and maintenance
Tipical Latin Food, Corporation Food and Cosmetics 12/23/2024 Food safety plan
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Manufacturing, processing, packing, holding – Controls
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Storage and Distribution
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Hazard analysis – Identification of hazard
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Sanitation preventive controls – Implement
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Allergen preventive controls – Appropriate (Adequate)
Today’s Frozen Desserts, Inc. Food and Cosmetics 09/13/2024 Supply-chain program – Assurance (Adequate)
Tomasino Farms, Inc. Food and Cosmetics 01/23/2024 Develop FSVP
USA Hemp Solutions Food and Cosmetics 09/05/2024 Personnel
USA Hemp Solutions Food and Cosmetics 09/05/2024 Plant construction and design
USA Hemp Solutions Food and Cosmetics 09/05/2024 Cleaning and sanitizing substances – Safe and adequate
USA Hemp Solutions Food and Cosmetics 09/05/2024 Food safety plan
Vivex Biologics, Inc. Biologics 01/12/2024 Changes to validated process
White Toque Florida Food and Cosmetics 09/04/2024 Pest control
Zenta, LLC Veterinary 08/23/2024 Hazard Analysis
Zenta, LLC Veterinary 08/23/2024 Preventive Controls
Zoila M. Alen, M.D. Drugs 02/09/2024 FD-1572, protocol compliance
Zoila M. Alen, M.D. Drugs 02/09/2024 Case history records- inadequate or inadequate


Related

Mario Díaz-Balart U.S. House of Representatives from Florida

Mario Díaz-Balart addresses tax relief, TSA pay issues, and Iran allegations in March posts

U.S. Congressman Mario Díaz-Balart shared updates on March 16 about local farm tax relief efforts, unpaid TSA workers during a government shutdown, and accusations against Iran following an attack.

Mario Díaz-Balart U.S. House of Representatives from Florida

Mario Díaz-Balart comments on law enforcement cooperation and Cuban protests

U.S. Congressman Mario Díaz-Balart posted about regional security efforts with Bolivia and ongoing unrest in Cuba on March 13-14, while also criticizing Senate Democrats over delayed federal paychecks.

Laura V. Swett, Chairman of Federal Energy Regulatory Commission (FERC)

Miami-Dade County’s lowest midgrade gas price recorded at $2.95 for week ending Mar. 7

The lowest price of midgrade gas in cities throughout Miami-Dade County was found at a single gas station in the week ending Mar. 7, according to customer reports submitted to GasBuddy.

Trending

The Weekly Newsletter

Sign-up for the Weekly Newsletter from North Miami-Dade News.