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 over the first quarter of 2024, 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 quarter.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• 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 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
Baxter Healthcare Corporation	Drugs	02/09/2024	Procedures not in writing, fully followed
Baxter Healthcare Corporation	Drugs	02/09/2024	Cleaning / Sanitizing / Maintenance
Baxter Healthcare Corporation	Drugs	02/09/2024	Absence of Written Procedures
Baxter Healthcare Corporation	Drugs	02/09/2024	Control procedures fail to include the following
Baxter Healthcare Corporation	Drugs	02/09/2024	Scientifically sound laboratory controls
Baxter Healthcare Corporation	Drugs	02/09/2024	Investigations of discrepancies, failures
Baxter Healthcare Corporation	Drugs	02/09/2024	Complaint Handling Procedure