Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.March 15, 2019

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

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Record Details

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.

Company: Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
Inspection Date: March 15, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Jose O. Hernandez (investigator)

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ID · 11986742-8e0e-4ced-bf79-d8c9ae313711