Ren Zhongju
Chengdu Innovation Pharmaceutical Co., Ltd.
No.123, 1st Floor, No 91 Zhongheng Street
Jinniu Qu
Chengdu Shi
Sichuan Sheng , 610036
ChinaFEI 3027222600Issued Feb 5, 2025Center 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 3027222600.
Violations2
Issue DateFeb 5, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Chengdu Innovation Pharmaceutical Co., Ltd.
Location
Ren Zhongju
Chengdu Innovation Pharmaceutical Co., Ltd.
No.123, 1st Floor, No 91 Zhongheng Street
Jinniu Qu
Chengdu Shi
Sichuan Sheng , 610036
China
FEI Number
3027222600
Country
China
Issue Date
February 05, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Chengdu Innovation Pharmaceutical Co., Ltd., a Chinese active pharmaceutical ingredient (API) manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) standards, resulting in adulterated drug products distributed to the United States. The facility did not perform identity testing on incoming production materials prior to release for manufacturing use, creating a significant gap in quality assurance and material verification. This critical deviation prevented the company from demonstrating that incoming materials met appropriate specifications before being incorporated into drug manufacturing processes.
Chengdu Innovation Pharmaceutical Co., Ltd. FDA Warning Letter, February 5, 2025
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