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Talk to a SpecialistTalk to a SpecialistAccupack Midwest, Inc., a drug manufacturer in Cincinnati, Ohio, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceuticals including sunscreens, anti-itch creams, and analgesics. The company failed to establish adequate laboratory controls and specifications for water used as a component in drug products, lacking appropriate limits and testing for objectionable microorganisms, total organic carbon, and conductivity. The FDA determined that these manufacturing deficiencies rendered the firm's drug products adulterated and non-compliant with 21 CFR parts 210 and 211, following an inspection conducted February 22-27, 2024, and subsequent teleconference discussions in June 2024.