# FDA 483 - Asymchem Life Science (Tianjin) Co., Ltd. - March 21, 2025

Source: https://www.globalkeysolutions.net/records/483/asymchem-life-science-tianjin-co-ltd/8e8cadb8-b4b3-41ec-b18a-c6dc65612ef8

> FDA 483 for Asymchem Life Science (Tianjin) Co., Ltd. on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asymchem Life Science (Tianjin) Co., Ltd.
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Asymchem Life Science (Tianjin) Co., Ltd., a drug manufacturer, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly review manufacturing discrepancies, maintain written procedures for its quality control unit, and implement adequate controls over computer systems for data backup. These issues indicate a lack of robust oversight in critical manufacturing and data management processes.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/asymchem-life-science-tianjin-co-ltd/ccb993d1-42a4-40fe-9c05-bf590f287eeb

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8