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Talk to a SpecialistTalk to a SpecialistCosmobeauti Laboratories & Manufacturing Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter sunscreen drug products. The company's quality control unit failed to provide adequate oversight and engaged in backdating batch production records, with the regulatory consultant and company president acknowledging they had backdated review steps rather than documenting activities at the time of performance. The FDA determined that because the firm's methods, facilities, and controls did not conform to CGMP regulations, the drug products were adulterated, and the company's response to the initial inspection findings was deemed inadequate for failing to provide sufficient detail or evidence of corrective actions.