# FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/93dc41ab-1075-4e3e-886b-7305749adeff

> FDA 483 for Tianjin Asymchem Pharmaceuticals Co., Ltd. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianjin Asymchem Pharmaceuticals Co., Ltd.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Tianjin Asymchem Pharmaceuticals Co., Ltd., an API manufacturer in TEDA West Tianjin, P.R. China, was cited for significant deficiencies in laboratory controls, including analytical method validation, release testing, and data validity. Additional observations noted inadequate procedures for establishing retest dates, failures in Quality Unit responsibilities, insufficient change control, and improper equipment surface construction. These issues indicate a lack of robust quality systems for API manufacturing.

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## Related Officers

- [Wenzheng Zhang](https://www.globalkeysolutions.net/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Marijo B. Kambere](https://www.globalkeysolutions.net/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.globalkeysolutions.net/companies/tianjin-asymchem-pharmaceuticals-co-ltd/1e469779-31a9-40d3-9bd8-d580e8489e7b

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