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Talk to a SpecialistTalk to a SpecialistColumbia Cosmetics Manufacturing Inc., a drug manufacturer of OTC sunscreen products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an April 2025 FDA inspection. The company failed to adequately investigate out-of-specification results, including a batch of subpotent active pharmaceutical ingredients that was reprocessed without Quality Unit review and approval, then released despite remaining subpotent in finished product testing. These manufacturing control deficiencies rendered the firm's drug products adulterated under federal law, as the company's methods, facilities, and controls did not conform to required CGMP standards.