Mr. Xiangqi Zhang
Vice General Manager
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
No. 20 Daming Street
Xiqing Qu
Tianjin Shi , 300112
China
jwhzxq@163.comFEI 3006283468Issued Oct 30, 2024Center 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 3006283468.
Mr. Xiangqi Zhang
Vice General Manager
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
No. 20 Daming Street
Xiqing Qu
Tianjin Shi , 300112
China
jwhzxq@163.com
FEI Number
3006283468
Country
China
Issue Date
October 30, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical drugs following an FDA inspection in March 2024. The company limited and refused FDA inspection access, particularly by restricting access to manufacturing records including process validation reports and batch production records, which constitutes drug adulteration under the Federal Food, Drug, and Cosmetic Act. These inspection obstruction actions, combined with non-conforming manufacturing methods, facilities, and controls, resulted in the company's drug products being deemed adulterated and unfit for distribution.
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. FDA Warning Letter, October 30, 2024
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