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Talk to a SpecialistTalk to a SpecialistUltra Seal Corporation's drug manufacturing facilities failed to maintain Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals, rendering their drug products adulterated. FDA inspectors identified significant violations including inadequate written procedures for cleaning and maintenance of non-dedicated equipment used to manufacture multiple OTC products, with incomplete cleaning validation studies that could not demonstrate adequate removal of drug residues and prevention of cross-contamination. The company's cleaning procedures lacked adequate specifications and the firm was unable to justify that their processes would prevent cross-contamination between different drug products manufactured on shared equipment.