Zhejiang Tianyu Pharmaceutical Co., Ltd.

Warning LetterClosed

Mr. Yongjun Tu Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical Co., Ltd. Jiangkou Development Zone Huangyan Qu Taizhou Shi Zhejiang Sheng , 318020 ChinaFEI 3010972581Issued Aug 17, 2022Center for Drug Evaluation and Research | CDER

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Letter Details

Firm: Zhejiang Tianyu Pharmaceutical Co., Ltd.
Location: Mr. Yongjun Tu Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical Co., Ltd. Jiangkou Development Zone Huangyan Qu Taizhou Shi Zhejiang Sheng , 318020 China
FEI Number: 3010972581
Country: China
Issue Date: August 17, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Closed
Closeout Letter: March 11, 2025

Summary

Zhejiang Tianyu Pharmaceutical Co., Ltd. was cited for significant current good manufacturing practice (CGMP) violations in the production of active pharmaceutical ingredients (APIs), resulting in adulterated drug products. During a February-March 2022 inspection, the FDA found that the company failed to conduct adequate investigations into batch failures, specifically identifying at least four lots that failed impurity specifications for one API but testing only eight of numerous lots manufactured under a non-optimized process. Most critically, the company continued releasing and distributing API lots for approximately three months without implementing mitigating controls, despite identifying that the impurity had a higher risk of forming and before validating an analytical method to detect it.

Zhejiang Tianyu Pharmaceutical Co., Ltd. FDA Warning Letter, August 17, 2022