FDA 483 - Pharmco Laboratories Inc. - March 20, 2025
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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.
ID · 307f08c1-f02f-4e7c-a0f8-9ee4b7257176