FDA 483 - Xinyu Pharmaceutical Co., Ltd. - June 27, 2025

During an inspection conducted from June 23 to June 27, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Xinyu Pharmaceutical Co., Ltd. The inspection revealed significant concerns regarding the company's adherence to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs).

Key observations included a critical failure in the Quality Assurance (QA) department's oversight, specifically its lack of review and approval for crucial quality-related documents such as finished product Certificates of Analysis and the release of raw, intermediate, and packaging materials.

Furthermore, the FDA noted deficiencies in equipment management. Manufacturing equipment for APIs was not properly identified in processing areas, batch records, or cleaning procedures, hindering operational clarity. A water system supplying workshops also lacked proper identification, exhibited an observed leak, and was located in an area with inadequate lighting. Another observation highlighted the continued use of damaged API manufacturing equipment without documented deviation or corrective actions.

Finally, the inspection found issues with the maintenance of API stability samples. A stability test chamber contained samples in an improperly secured container, potentially compromising the integrity of data used for assigning retest or expiry dates.

These observations indicate a need for Xinyu Pharmaceutical Co., Ltd. to implement comprehensive corrective actions to address these quality system deficiencies and ensure compliance with regulatory standards for pharmaceutical manufacturing.