Shandong Anhong Pharmaceutical Co., Ltd. – FDA 483, Jun 26, 2026

An FDA inspection of Shandong Anhong Pharmaceutical Co., Ltd., a sterile and non-sterile API manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate measures to prevent cross-contamination, insufficient investigation of microbial excursions, and poorly developed or followed aseptic procedures. Additionally, the firm failed to validate critical water systems and equipment reuse, and maintained an older QC building in a poor state of repair.