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Talk to a SpecialistTalk to a SpecialistBEO Pharma Inc. violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutical drugs, resulting in adulterated products, during an FDA inspection conducted October 16 to November 4, 2024. The company failed to adequately test incoming components for identity and conformity with specifications, particularly active pharmaceutical ingredients (APIs) used in over-the-counter liquid drug products, and relied on supplier certificates of analysis without establishing the reliability of those suppliers' testing at appropriate intervals, as required by 21 CFR 211.84(d). The facility did not conform to required methods, facilities, or controls for manufacturing, processing, packing, or holding of drug products.