# FDA 483 - Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd. - March 15, 2019

Source: https://www.keypedia.com/records/483/yung-shin-pharmaceutical-industrial-kunshan-co-ltd/11986742-8e0e-4ced-bf79-d8c9ae313711

> FDA 483 for Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd. on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd., a drug manufacturer in Kunshan, China, was cited for two observations during an FDA inspection. The firm failed to follow written procedures for reporting laboratory deviations and lacked procedures for re-starting or manually discontinuing test runs. Additionally, the company changed suppliers for impurity standards without conducting proper supplier and materials qualification.

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)

Company: https://www.keypedia.com/companies/yung-shin-pharmaceutical-industrial-kunshan-co-ltd/52588ff7-25f2-4e7c-8345-e23d3aaef916

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