Hydrox Chemical Company Inc – FDA EIR, Jan 24, 2020

Hydrox Laboratories, an OTC drug and cosmetic manufacturer in Elgin, IL, underwent a routine comprehensive Good Manufacturing Practice (GMP) surveillance inspection by the FDA from January 22 to 24, 2020. This inspection, conducted under Compliance program 7356.002 for Drug Manufacturing, specifically focused on the company's Over-The-Counter (OTC) drug products and associated GMP compliance, not covering cosmetics. Notably, the inspection concluded with no FDA Form 483 Inspectional Observations issued, indicating overall compliance with regulatory standards. The report highlighted that previous drug-related observations from a 2016 inspection were addressed. These prior issues included products failing to meet specifications not always being rejected, insufficient investigation of microbiology laboratory failures and other significant failures, deficient management of the long-term stability program, and improper validation and control of the USP system. Hydrox Laboratories successfully corrected these deficiencies, now consistently rejecting non-conforming products, conducting thorough investigations, ensuring proper validation and control of their systems, and clearly identifying processing lines and major equipment.