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

Pharmco Laboratories Inc., a contract manufacturer of human drug products in Titusville, FL, was cited for significant deficiencies across multiple areas of its operations. The inspection revealed critical issues including uninvestigated out-of-specification microbiology results for the water system, inadequate laboratory controls, and poorly designed and maintained equipment. These findings indicate a systemic failure to adhere to cGMP regulations, with several observations being repeats from prior inspections.