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Professional Disposables International, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of drug products at its Orangeburg, New York facility during a 2021 inspection. The company failed to thoroughly investigate out-of-specification (OOS) test results and unexplained discrepancies in batches or components, and failed to submit required NDA Field Alert reports to the FDA within the mandated three-working-day timeframe for bacteriological contamination or significant changes in distributed products. These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.