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

Source: https://www.keypedia.com/records/483/wuxi-fortune-pharmaceutical-co-ltd/df20d95e-9b02-48b4-a766-693c46f26888

> FDA 483 for Wuxi Fortune Pharmaceutical Co., Ltd. on September 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Fortune Pharmaceutical Co., Ltd.
- Inspection Date: 2023-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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).

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.keypedia.com/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.keypedia.com/companies/wuxi-fortune-pharmaceutical-co-ltd/d02f3e8d-af2b-4b82-b2ae-6fc25c005e95

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