Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistABR Laboratory LLC, a contract testing laboratory in Hollywood, Florida, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the testing of finished pharmaceutical products. The FDA found that the firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods as required by 21 CFR 211.165(e), specifically using growth media compositions that differed from United States Pharmacopeia (USP) standards without demonstrating equivalence or superiority for microbial contamination testing of over-the-counter drug products. These control and methodology failures rendered the drug products tested by the firm adulterated under the Federal Food, Drug, and Cosmetic Act. The inspection was conducted September 9-13, 2024, with the warning letter issued February 10, 2025.