Mr. Zhan Libin
General Manager
Hangzhou Huiji Biotechnology Co., Ltd.
No. 3 Shunshuiqiao Road
Renhe Street
Yuhang Qu
Hangzhou Shi
Zhejiang Sheng , 310012FEI 3010461961Issued Nov 18, 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 3010461961.
Violations5
Issue DateNov 18, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Hangzhou Huiji Biotechnology Co., Ltd.
Location
Mr. Zhan Libin
General Manager
Hangzhou Huiji Biotechnology Co., Ltd.
No. 3 Shunshuiqiao Road
Renhe Street
Yuhang Qu
Hangzhou Shi
Zhejiang Sheng , 310012
FEI Number
3010461961
Country
China
Issue Date
November 18, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Hangzhou Huiji Biotechnology Co., Ltd., an OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their products adulterated. The company failed to conduct required identity testing on incoming drug components prior to use in manufacturing, including ethyl alcohol used in gel hand sanitizers, and did not demonstrate adequate verification of raw materials across shipments. These violations of 21 CFR 211.84(d)(1) indicated that the firm's methods, facilities, and controls for manufacturing, processing, and holding drugs did not conform to CGMP standards.
Hangzhou Huiji Biotechnology Co., Ltd. FDA Warning Letter, November 18, 2024
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