Asymchem Life Science (Tianjin) Co., Ltd. (CMM site) – FDA 483, Jul 2, 2026
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.
- Inspection date
- July 2, 2026
- Product type
- drugs
ID · 9bf54605-ec27-4075-99a5-226a5ecaee76
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