# Asymchem Life Science (Tianjin) Co., Ltd. (CMM site) – FDA 483, Jul 2, 2026

Source: https://www.keypedia.com/records/483/asymchem-life-science-tianjin-co-ltd-cmm-site/9bf54605-ec27-4075-99a5-226a5ecaee76

> FDA 483 for Asymchem Life Science (Tianjin) Co., Ltd. (CMM site) on July 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asymchem Life Science (Tianjin) Co., Ltd. (CMM site)
- Inspection Date: 2026-07-02
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Asymchem Life Science (Tianjin) Co., Ltd., a contract API manufacturer, identified deficiencies in their procedures for preventing microbiological contamination and ensuring the reliability of endotoxin testing. Specifically, a microbiologist failed to follow the gel clot method procedure, and the firm lacked data demonstrating the suitability of sampling tubes for endotoxin testing. These issues could lead to false negative endotoxin test results, posing a risk to product quality.

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.keypedia.com/companies/asymchem-life-science-tianjin-co-ltd-cmm-site/5f499bc8-6e44-41f7-b19d-0082311208de

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