FDA 483 - Apothecus Pharmaceutical Corp. - October 06, 2023

An FDA inspection conducted at Apothecus Pharmaceutical Corp. in Hicksville, NY, from September 13 to October 6, 2023, identified significant deviations from regulatory standards for pharmaceutical manufacturing. The inspection revealed a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results for products like VCF Contraceptive Film and Gel, often concluding without adequate root cause identification or assessment of production processes. This included releasing product before investigations were complete and failing to evaluate customer complaints properly. Further issues included inadequate testing of incoming raw materials, such as Propylene Glycol and Glycerin, for critical impurities, and a lack of periodic validation for supplier analyses. The company's quality control unit released drug products (VCF Contraceptive Film) without completing essential batch record reviews, citing customer demand, which compromises product approval authority. The firm also produced commercial batches of VCF Contraceptive Gel significantly exceeding previously validated process sizes, indicating a failure in establishing adequate production and process controls. Additionally, there was insufficient control over labeling, with lot-numbered labels left unsecured, and a lack of change control documentation for major equipment installations and increases in batch sizes. These observations highlight non-compliance with Good Manufacturing Practices, requiring Apothecus Pharmaceutical Corp. to implement comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory adherence.