FDA 483 - Hisun Pharmaceutical (Nantong) Co., Ltd. - July 12, 2024

During an inspection conducted from July 8-12, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Hisun Pharmaceutical (Nantong) Co., Ltd., an API manufacturer in China, highlighting significant observations regarding their manufacturing practices. The document outlines several deficiencies that require immediate attention to ensure compliance with quality standards.

Key observations include the failure to review and approve changes to written procedures by the quality control unit. Specifically, a new sampling device was introduced without proper change control, resulting in an unknown impurity. The FDA also noted that deviations from process control procedures were not adequately recorded or justified, with corrective actions (CAPAs) being insufficient, such as incomplete training for sampling techniques leading to recurring errors.

Furthermore, observations detailed that equipment and utensils were not consistently cleaned or maintained to prevent contamination. Examples cited include worn gaskets and foreign material found in equipment designated as "cleaned." The inspection also revealed a lack of adequate written procedures for cleaning equipment and its subsequent release for use, specifically missing instructions for comprehensive visual inspections.

Hisun Pharmaceutical (Nantong) Co., Ltd. is required to thoroughly investigate and address these observations, implementing robust corrective and preventive actions to ensure the quality, purity, and safety of their drug substances, thereby adhering to regulatory expectations.