FDA 483 - Hydrox Laboratories - June 24, 2021

Hydrox Laboratories in Elgin, IL, was inspected by the FDA and received a Form 483 with nine observations indicating significant deficiencies in quality control and manufacturing practices. The inspection revealed failures in microbial testing, equipment cleaning and maintenance, adherence to written procedures, and the investigation of discrepancies and out-of-specification results. These issues suggest a systemic lack of control over critical aspects of drug product manufacturing, potentially impacting product safety and quality.