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Talk to a SpecialistTalk to a SpecialistDarmerica, LLC was warned for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Florida, resulting in adulterated active pharmaceutical ingredients (APIs) that were introduced into interstate commerce. The company's violations included deviations from CGMP standards for manufacturing, processing, packing, and holding of APIs, as well as distribution of misbranded drugs with false or misleading labeling, inadequate directions for use, and failure to properly list drugs in accordance with FDA requirements. The FDA conducted an inspection from March 3-19, 2025, and reviewed the company's response submitted on April 7, 2025, before issuing this enforcement action.