FDA 483 - AHC Products Inc - March 29, 2022

AHC Products Inc., an animal drug manufacturer in Winchester, KY, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate component testing, stability testing, OOS investigations, labeling procedures, equipment maintenance, and complaint handling. These issues indicate a systemic lack of adherence to good manufacturing practices, posing potential risks to product quality and patient safety.