# FDA 483 - Yangzhou Liberty Pharmaceuticals Co. Ltd. - September 15, 2023

Source: https://www.keypedia.com/records/483/yangzhou-liberty-pharmaceuticals-co-ltd/d5b740e8-ecd6-4fea-8c56-0ea875feb9a7

> FDA 483 for Yangzhou Liberty Pharmaceuticals Co. Ltd. on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yangzhou Liberty Pharmaceuticals Co. Ltd.
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Yangzhou Liberty Pharmaceuticals Co. Ltd. in Yangzhou, China, an API manufacturer, revealed a significant issue with equipment maintenance. Specifically, a worn and fractured gasket in a tank used for API manufacturing was observed, and the firm's procedures did not include visual inspection of such gaskets prior to use, leading to potentially compromised batches shipped to the U.S.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/yangzhou-liberty-pharmaceuticals-co-ltd/71823610-ebd0-4493-876d-9694002c8995

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