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Cosmetic Solutions, LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Boca Raton, Florida, following an FDA inspection in September 2023. The company failed to establish adequate written responsibilities and procedures for its quality control unit and did not provide proper oversight of over-the-counter drug manufacturing processes, including failure to follow stability testing procedures for multiple product batches. Additionally, certain drug products were found to be unapproved new drugs introduced into interstate commerce in violation of federal law. The violations rendered the firm's drug products adulterated and subject to regulatory enforcement action.