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

Source: https://www.keypedia.com/records/483/jiangsu-anbison-pharmaceutical-co-ltd/1f011bf3-2306-4f24-b98b-4d3da465772e

> FDA 483 for Jiangsu Anbison Pharmaceutical Co., Ltd. on August 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Anbison Pharmaceutical Co., Ltd.
- Inspection Date: 2023-08-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/jiangsu-anbison-pharmaceutical-co-ltd/f9324a6c-1ec8-40eb-8148-73c13ea386df

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1