FDA 483 - Hydrox Chemical Company Inc - July 25, 2025

Hydrox Chemical Company dba Hydrox Laboratories in Elgin, IL, was inspected and received nine observations related to significant deficiencies in their manufacturing and quality control processes. Key issues include inadequate investigations into product discrepancies and customer complaints, poor facility design and maintenance leading to contamination risks, and insufficient laboratory and stability testing. These findings indicate a broad failure to adhere to cGMP requirements, potentially impacting drug product quality, purity, and safety.