FDA 483 - Aucta Pharmaceuticals, Inc. - June 07, 2023

Aucta Pharmaceuticals, Inc. in Piscataway, NJ, a finished dosage manufacturer, was inspected and cited for significant deficiencies across its quality control, production, and process control systems. Observations included inadequate test method validation, lack of specifications for purified water, unsuitable equipment location and qualification, poor humidity control, and failures in OOS investigations and quality unit oversight. These issues indicate a lack of robust controls to assure drug product quality and purity.