Montgomery News

There were five companies in cities associated with Montgomery County that received FDA citations as a result of five inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 61.5% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not develop an FSVP.
• Your hazard analysis did not identify a hazard that requires a control.
• You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.

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
Cima Food, Inc.	Food and Cosmetics	05/26/2023	Food safety plan
Cima Food, Inc.	Food and Cosmetics	05/26/2023	Hazard analysis - Conducted
Cima Food, Inc.	Food and Cosmetics	05/26/2023	PCQI training records
GCDMV, LLC	Food and Cosmetics	07/24/2023	Hazard analysis biological, chemical, physical
GCDMV, LLC	Food and Cosmetics	07/24/2023	Evaluation - performance, risk
GCDMV, LLC	Food and Cosmetics	07/24/2023	Approved supplier procedures - importer established
GCDMV, LLC	Food and Cosmetics	07/24/2023	Verification activity - another entity, assess
GCDMV, LLC	Food and Cosmetics	07/24/2023	Verification activity review, assess
GCDMV, LLC	Food and Cosmetics	07/24/2023	Record - sign, date
Reveragen Biopharma, Inc.	Drugs	03/06/2023	Shipment to unauthorized persons
Reveragen Biopharma, Inc.	Drugs	03/06/2023	Investigator non-compliance
Sabouya International Foods, LLC	Food and Cosmetics	10/31/2023	Develop FSVP
Wayne Farnsworth, M.D.	Biologics	06/27/2023	FD-1572, protocol compliance