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

An FDA inspection of Apothecus Pharmaceutical Corp., a manufacturer located in Hicksville, NY, was conducted from September 13 to October 6, 2023. The inspection resulted in a Form FDA 483, identifying multiple observations indicating deviations from current Good Manufacturing Practices (cGMP) as enforced under the Federal Food, Drug, and Cosmetic Act. The primary issues noted involved significant failures in quality control and production processes. Specifically, the firm inadequately investigated out-of-specification (OOS) results for VCF Contraceptive Film and Gel, often releasing affected products without determining root causes or assessing potential impacts on other distributed lots. There was also a failure to perform complete identity testing on critical incoming components, such as Propylene Glycol and Glycerin, and to periodically validate supplier certificates of analysis. Further observations highlighted that the quality control unit lacked full authority, releasing drug product lots prematurely due to "customer demand" before completing batch record reviews. The company also failed to adequately validate production processes for significantly increased batch sizes of VCF Contraceptive Gel that exceeded validated parameters. Labeling controls were insufficient, with lot-numbered labels left unsecured. Moreover, critical process changes, including new equipment installations and batch size increases, were not managed through formal change control documentation. These findings necessitate Apothecus Pharmaceutical Corp. to undertake comprehensive corrective and preventive actions to rectify the deficiencies and ensure ongoing regulatory compliance.