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Talk to a SpecialistTalk to a SpecialistWinder Laboratories, LLC, a drug manufacturer in Georgia, failed to maintain adequate Current Good Manufacturing Practice (CGMP) controls for finished pharmaceuticals, rendering their drug products adulterated. FDA inspectors found that the company did not properly clean, maintain, sanitize, or sterilize manufacturing equipment at appropriate intervals, with multiple pieces of equipment—including a tablet press and dedicated manufacturing lines—showing drug product residue and oxidized metal surfaces despite being documented as clean and released by quality assurance. The firm lacked adequate written procedures for equipment cleaning and maintenance, and failed to prevent contamination that could alter the safety, identity, strength, and purity of prescription tablet products.