FDA 483 - Chemco Corporation - October 31, 2022

Chemco Corporation, a manufacturer of cosmetics and OTC drugs in Miami Lakes, FL, was cited for significant deficiencies across its laboratory, equipment, and quality systems. The inspection revealed failures in microbiological testing, inadequate laboratory data review, poorly maintained and qualified water systems, insufficient equipment cleaning verification, and a systemic failure to investigate out-of-specification results and objectionable organism findings. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.