FDA 483 - Pharmco Laboratories Inc. - March 20, 2025

Pharmco Laboratories Inc. in Titusville, FL, a contract manufacturer of human drug products, received a Form FDA 483 citing significant deficiencies across its operations. Key issues include uninvestigated out-of-specification water system results, inadequate laboratory controls for material testing, poorly designed and maintained equipment, and a systemic lack of quality unit oversight. These repeat observations indicate a failure to ensure the quality and purity of drug products.