North Miami-Dade News

There were 11 companies in cities associated with Miami-Dade County that received FDA citations as a result of 11 inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 45% decrease from the number of companies cited in the previous quarter.

Of the 32 citations issued, the most common citations were 'Written MDR procedures have not been developed' and 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector.

All of the companies cited should take voluntary actions to correct their managing operations.

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.

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, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
American Medical Endoscopy, Inc.	Devices	10/11/2023	Lack of Written MDR Procedures
Aztlan Foods, Corporation	Food and Cosmetics	11/28/2023	Sanitation preventive controls - Appropriate (Adequate)
Aztlan Foods, Corporation	Food and Cosmetics	11/28/2023	Supply-chain program - Establish
CFS Dental, Inc.	Devices	10/31/2023	Evaluation and Selection, Suppliers, Contractors, etc.
Casmol, LLC	Food and Cosmetics	10/10/2023	Plant construction and design
Casmol, LLC	Food and Cosmetics	10/10/2023	Sanitation of food-contact surfaces - Frequency
Casmol, LLC	Food and Cosmetics	10/10/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Casmol, LLC	Food and Cosmetics	10/10/2023	Sanitary facilities and controls
Casmol, LLC	Food and Cosmetics	10/10/2023	Equipment and utensils - Design and maintenance
Century Farms International	Food and Cosmetics	12/08/2023	Develop FSVP
Florida Smoked Fish, LLC	Food and Cosmetics	10/18/2023	HACCP plan implementation
Florida Smoked Fish, LLC	Food and Cosmetics	10/18/2023	Critical limits
Florida Smoked Fish, LLC	Food and Cosmetics	10/18/2023	Monitoring - adequacy
Florida Smoked Fish, LLC	Food and Cosmetics	10/18/2023	Corrective action plan
Florida Smoked Fish, LLC	Food and Cosmetics	10/18/2023	Sanitation monitoring
Healthtex Distributors, Inc.	Food and Cosmetics	12/01/2023	Personnel - quality control operations; responsibilities
Healthtex Distributors, Inc.	Food and Cosmetics	12/01/2023	Written procedure quality control operations material review
Healthtex Distributors, Inc.	Food and Cosmetics	12/01/2023	Written procedures - holding
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Component - verify identity, dietary ingredient
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Component - qualify supplier
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Written procedures - quality control operations
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Master manufacturing record - unique formulation
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Batch record - every batch
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Written procedures - holding
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Records - returned dietary supplement: written procedures
Natural Ginger, Corporation	Food and Cosmetics	12/22/2023	Written procedures - product complaint; review, investigate
Scientific Supplies & Technology, Inc.	Devices	11/09/2023	Lack of Written MDR Procedures
Scientific Supplies & Technology, Inc.	Devices	11/09/2023	Lack of or inadequate procedures
Scientific Supplies & Technology, Inc.	Devices	11/09/2023	DHR - not or inadequately maintained
Scientific Supplies & Technology, Inc.	Devices	11/09/2023	Lack of or inadequate complaint procedures
Sunsof, Inc.	Food and Cosmetics	12/14/2023	Hazard analysis - Identification of hazard
The Green Fruit Company, LLC	Food and Cosmetics	11/03/2023	Develop FSVP