Recipient Name Mr. Qi-Lian He General Manager, Recipient Title Mr. Qi-Lian He General Manager, Sanrace Biotechnology Co., Ltd., 268 Yanzhou Road Lanxi Development Zone Lanxi Shi Jinhua Shi Zhejiang Sheng , 321102 China, (b)(4)FEI 3016897521Issued Oct 22, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016897521.
Violations4
Issue DateOct 22, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Sanrace Biotechnology Co., Ltd.
Location
Recipient Name Mr. Qi-Lian He General Manager, Recipient Title Mr. Qi-Lian He General Manager, Sanrace Biotechnology Co., Ltd., 268 Yanzhou Road Lanxi Development Zone Lanxi Shi Jinhua Shi Zhejiang Sheng , 321102 China, (b)(4)
FEI Number
3016897521
Country
China
Issue Date
October 22, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated
Sanrace Biotechnology Co., Ltd. FDA Warning Letter, October 22, 2026
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