Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) – FDA 483, May 15, 2026

An FDA inspection of Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., an API and Drug Manufacturer in Nanjing, China, revealed significant deficiencies across multiple areas. Observations included inadequate cleaning programs and validation for manufacturing equipment, insufficient investigations into out-of-specification (OOS) results, and failures in laboratory controls regarding scientifically sound test procedures and stability sample handling. These issues indicate a lack of robust quality control and manufacturing practices that could impact product safety and purity.