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Talk to a SpecialistTalk to a SpecialistAbsolutely Natural, an over-the-counter drug manufacturer in Melbourne, Florida, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. During an April 2025 inspection, FDA investigators found that the company failed to thoroughly investigate an out-of-specification batch that showed microbiological contamination (elevated total plate count and Pseudomonas aeruginosa in July 2024), did not adequately assess root causes, and did not extend the investigation to other potentially affected batches as required by 21 CFR 211.192. The company's methods, facilities, and controls for manufacturing, processing, packing, and holding did not conform to CGMP standards, posing potential safety risks to consumers.