FDA 483 - Apex International Mfg., LLC - August 11, 2023

An FDA inspection of Apex International Mfg, LLC in Chaska, MN, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to adequately verify the identity of drug product components, including testing for harmful impurities like methanol, diethylene glycol, and ethylene glycol. Additionally, the inspection found issues with computer system controls, data integrity, and a lack of proper procedures for equipment cleaning and maintenance.