Jiangsu Anbison Pharmaceutical Co., Ltd.August 14, 2023

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

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Record Details

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.

Company: Jiangsu Anbison Pharmaceutical Co., Ltd.
Inspection Date: August 14, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Michele L. Glendenning

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