Huifang Mao
Deqing Jiarou Daily Chemical Co., Ltd.
Wuzling, Chengshan Village, Wukang Town
Deqing Xian
Huzhou Shi
Zhejiang Sheng , 313299
ChinaFEI 3013042669Issued Mar 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 3013042669.
Violations5
Issue DateMar 18, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Deqing Jiarou Daily Chemical Co., Ltd.
Location
Huifang Mao
Deqing Jiarou Daily Chemical Co., Ltd.
Wuzling, Chengshan Village, Wukang Town
Deqing Xian
Huzhou Shi
Zhejiang Sheng , 313299
China
FEI Number
3013042669
Country
China
Issue Date
March 18, 2024
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Deqing Jiarou Daily Chemical Co., Ltd., a Chinese manufacturer of over-the-counter drug products including antibacterial hand sanitizer, failed to conduct adequate identity testing of incoming components and active ingredients, particularly not testing ethanol for methanol contamination. The company's manufacturing methods, facilities, and controls did not conform to Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211, rendering their drug products adulterated. This warning was issued on March 18, 2024, following FDA's review of records submitted in response to a September 2022 records request.
Deqing Jiarou Daily Chemical Co., Ltd. FDA Warning Letter, March 18, 2024
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