Alex Hua
Sales Director
Zhejiang Easyclean Daily Chemical Co., Ltd
501168, Dongrui 4th Road
Xintang Street
Xiaoshan Qu
Hangzhou Shi
Zhejiang Sheng , 311200FEI 3016734050Issued May 14, 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 3016734050.
Violations6
Issue DateMay 14, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Zhejiang Easyclean Daily Chemical Co., Ltd
Location
Alex Hua
Sales Director
Zhejiang Easyclean Daily Chemical Co., Ltd
501168, Dongrui 4th Road
Xintang Street
Xiaoshan Qu
Hangzhou Shi
Zhejiang Sheng , 311200
FEI Number
3016734050
Country
China
Issue Date
May 14, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Zhejiang Easyclean Daily Chemical Co., Ltd, a Chinese manufacturer of over-the-counter drug products, failed to conduct adequate finished product testing to verify the identity and strength of active ingredients prior to release to the U.S. market, in violation of Current Good Manufacturing Practice (CGMP) regulations. The company's inability to provide appropriate laboratory testing for batch conformance to final specifications meant its drug products were adulterated and lacked scientific evidence of proper ingredient content. This compliance failure was identified through FDA's review of records submitted in response to a March 2024 inspection request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.
Zhejiang Easyclean Daily Chemical Co., Ltd FDA Warning Letter, May 14, 2025