Cobb Reporter

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

This is a 33.3% increase over the number of companies cited in the previous year.

The citations in the county include:

• Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
• Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Most of the companies cited were involved in the Biologics sector.

Of the companies cited, two should take voluntary actions to correct their managing operations (50%). Additionally, two companies had to take regulatory and/or administrative actions (50%).

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
Advance Medical Designs, Inc.	Devices	06/30/2023	Design review - Lack of or inadequate procedures
Advance Medical Designs, Inc.	Devices	06/30/2023	Design history file
Advance Medical Designs, Inc.	Devices	06/30/2023	Evaluation of suppliers, contractors, etc., requirements
Advance Medical Designs, Inc.	Devices	06/30/2023	DMR - not or inadequately maintained
MiMedx Group, Inc.	Biologics	03/02/2023	Component identification test
MiMedx Group, Inc.	Biologics	03/02/2023	Absence of Written Procedures
MiMedx Group, Inc.	Biologics	03/02/2023	Scientifically sound laboratory controls
MiMedx Group, Inc.	Biologics	03/02/2023	Testing and release for distribution
MiMedx Group, Inc.	Biologics	03/02/2023	Adequate number of batches on stability
MiMedx Group, Inc.	Biologics	03/02/2023	Master production and control records, procedure
MiMedx Group, Inc.	Biologics	03/02/2023	Strict control not exercised over labeling issued
Reddy Naturals, LLC	Food and Cosmetics	08/02/2023	Master manufacturing record - each batch