FDA 483 - Shaanxi Hanjiang Pharmaceutical Group Co., Ltd (Gaoxin site) - September 18, 2023

Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. in Hanzhong City, China, an animal drug API manufacturer, was cited for four observations during an FDA inspection. The inspection revealed deficiencies in laboratory OOS/OOT procedures, inadequate investigation of discrepancies like shipping complaints, insufficient detail in written procedures for cleaning and raw material sampling, and incomplete production records. These issues indicate a need for improved quality control and documentation practices.