FDA 483 - Hunan Xiangyikang Pharmaceutical Co., Ltd. - November 21, 2025

Hunan Xiangyikang Pharmaceutical Co., Ltd., an API manufacturer, was cited for significant deficiencies across its facilities, quality, laboratory, production, and materials systems. Key issues include poorly maintained and cleaned equipment, failure to investigate laboratory discrepancies and validate test methods, and inadequate stability, process validation, cleaning risk assessment, and supplier qualification programs. These observations indicate a broad lack of control over critical manufacturing and quality processes, potentially impacting the quality and purity of APIs shipped to the U.S. market.