North Fulton Today

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

This is a 100% increase over the number of companies cited in the previous quarter.

The citations in the county 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.

Both companies cited were involved in either Drugs or Devices sectors.

Both 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
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