Foothills Review

There was one company in a city associated with McDowell 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• 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.

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
Baxter Healthcare Corporation	Biologics	10/31/2023	Equipment Design, Size and Location
Baxter Healthcare Corporation	Biologics	10/31/2023	Cleaning / Sanitizing / Maintenance
Baxter Healthcare Corporation	Biologics	10/31/2023	Absence of Written Procedures
Baxter Healthcare Corporation	Biologics	10/31/2023	In-process conformity - examination, sample testing
Baxter Healthcare Corporation	Biologics	10/31/2023	Lab controls established, including changes