FDA 483 - Wuxi Fortune Pharmaceutical Co., Ltd. - September 13, 2023

An FDA inspection of Wuxi Fortune Pharmaceutical Co., Ltd in Wuxi City, China, revealed significant deficiencies in their manufacturing processes. Observations included a lack of qualification for critical manufacturing equipment and systems, and failures to record and justify deviations from written production procedures. Additionally, the firm did not perform identity and quality testing for incoming Active Pharmaceutical Ingredient (API).