SE Atlanta News

There was one company in a city associated with Rockdale County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing.
• Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
• Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

The company cited was involved in the Drugs sector.

The company cited had to take regulatory and/or administrative actions.

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
ABC Compounding Company, Inc.	Drugs	04/21/2023	Procedures not in writing, fully followed
ABC Compounding Company, Inc.	Drugs	04/21/2023	Cleaning SOPs/instructions
ABC Compounding Company, Inc.	Drugs	04/21/2023	Establish reliability of supplier's C of A
ABC Compounding Company, Inc.	Drugs	04/21/2023	Control procedures to monitor and validate performance
ABC Compounding Company, Inc.	Drugs	04/21/2023	Establishment of time limitations
ABC Compounding Company, Inc.	Drugs	04/21/2023	Reprocessing procedures lack steps to be taken
ABC Compounding Company, Inc.	Drugs	04/21/2023	Expiration date lacking
ABC Compounding Company, Inc.	Drugs	04/21/2023	Scientifically sound laboratory controls
ABC Compounding Company, Inc.	Drugs	04/21/2023	Drug products - samples representative, identified properly
ABC Compounding Company, Inc.	Drugs	04/21/2023	Failing drug products not rejected
ABC Compounding Company, Inc.	Drugs	04/21/2023	Sample size - test intervals
ABC Compounding Company, Inc.	Drugs	04/21/2023	Written records kept in individual logs