FDA 483 - Jiangsu Anbison Pharmaceutical Co., Ltd. - August 14, 2023

An FDA inspection of Anbison Pharmaceutical Co., Ltd. in Taizhou, China, revealed a significant issue with equipment design and qualification. The firm's equipment qualifications for a critical manufacturing process lacked sufficient robustness tests, failing to ensure consistency and potentially impacting finished drug product quality. This indicates a concern regarding the firm's control over its manufacturing processes.