DeKalb GA News

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

This is a 71.4% decrease from the number of companies cited in the previous year.

Of the 17 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.

Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).

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
Commerce International, Inc.	Food and Cosmetics	09/15/2023	Plant construction and design
Commerce International, Inc.	Food and Cosmetics	09/15/2023	Sanitary operations - Plant maintenance
Food Ingredient Sales, Inc.	Food and Cosmetics	10/27/2023	Raw materials controls - Natural toxins
Food Ingredient Sales, Inc.	Food and Cosmetics	10/27/2023	Process control - Foreign objects
Kor- Chem, Inc.	Drugs	05/05/2023	Procedures not in writing, fully followed
Kor- Chem, Inc.	Drugs	05/05/2023	Training--operations, GMPs, written procedures
Kor- Chem, Inc.	Drugs	05/05/2023	Reports of Analysis (Components)
Kor- Chem, Inc.	Drugs	05/05/2023	Control procedures to monitor and validate performance
Kor- Chem, Inc.	Drugs	05/05/2023	Expiration date lacking
Kor- Chem, Inc.	Drugs	05/05/2023	Scientifically sound laboratory controls
Kor- Chem, Inc.	Drugs	05/05/2023	Microbiological testing
Kor- Chem, Inc.	Drugs	05/05/2023	Specific information required in individual logs
Kor- Chem, Inc.	Drugs	05/05/2023	Complete instructions, procedures, specifications et. al.
Kor- Chem, Inc.	Drugs	05/05/2023	Investigations of discrepancies, failures
San Antonio Bakery Solutions, LLC	Food and Cosmetics	03/15/2023	Develop FSVP
Selamta, LLC	Food and Cosmetics	08/17/2023	Develop FSVP
United Wholesale, LLC	Food and Cosmetics	06/14/2023	Evaluation - performance, risk