FDA 483 - Zhejiang Ausun Pharmaceutical Co., Ltd.

An FDA inspection of Zhejiang Ausun Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient manufacturer in Zhejiang, China, revealed three observations. The findings primarily concern discrepancies in critical process parameter results, inadequate error correction procedures for controlled documents, and a lack of calibrated clocks in areas where time entries are made into batch production records. These issues indicate deficiencies in data integrity and quality control practices.