# FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - October 19, 2021

Source: https://www.keypedia.com/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/10943e20-ad7a-4315-8d4a-731ff65193d0

> FDA 483 for Tianjin Asymchem Pharmaceuticals Co., Ltd. on October 19, 2021. 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: 2021-10-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Tianjin Asychem Pharmaceuticals Co., Ltd. in TEDA West Tianjin was inspected by the FDA from October 13-19, 2021. The inspection revealed a significant issue regarding the firm's inadequate supplier qualification process for a registered starting material. This deficiency indicates a lack of proper oversight in ensuring the quality and manufacturing practices of their suppliers.

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## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

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

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