ATL Standard

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

This is a 57.9% decrease from the number of companies cited in the previous year.

Of the 27 citations issued, the most common citations include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Most of the companies cited were involved in either Drugs or Food and Cosmetics sectors.

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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
Acella Pharmaceuticals, LLC	Drugs	02/10/2023	Approve or reject procedures or specs
Acella Pharmaceuticals, LLC	Drugs	02/10/2023	Scientifically sound laboratory controls
Acella Pharmaceuticals, LLC	Drugs	02/10/2023	Investigations of discrepancies, failures
Acella Pharmaceuticals, LLC	Drugs	02/10/2023	Procedures to be written and followed
Avanos Medical, Inc.	Devices	12/15/2023	Design Validation - Risk analysis not performed/inadequate
Avanos Medical, Inc.	Devices	12/15/2023	Lack of or inadequate procedures
Avanos Medical, Inc.	Devices	12/15/2023	Lack of or inadequate complaint procedures
Avion Pharmaceuticals, LLC	Drugs	11/08/2023	Procedures not in writing, fully followed
Avion Pharmaceuticals, LLC	Drugs	11/08/2023	Control procedures to monitor and validate performance
Avion Pharmaceuticals, LLC	Drugs	11/08/2023	Investigations of discrepancies, failures
Avion Pharmaceuticals, LLC	Drugs	11/08/2023	Returned drug procedures in writing and followed
Dester Corporation	Food and Cosmetics	03/23/2023	Develop FSVP
Dynamic Technical Formulations, LLC	Food and Cosmetics	08/22/2023	Specifications - component identity
Dynamic Technical Formulations, LLC	Food and Cosmetics	08/22/2023	Specifications met - identity, purity, strength, composition
Dynamic Technical Formulations, LLC	Food and Cosmetics	08/22/2023	Records - ret'nd dietary supplement: material review, dispos
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
O&M Halyard, Inc.	Devices	04/27/2023	Individual Report of Malfunction
San Antonio Bakery Solutions, LLC	Food and Cosmetics	03/15/2023	Develop FSVP