Fang Yongliang
Manager
Shantou Kangjie Daily Chemical Industry Co., Ltd
Kangjie Company, Xiangang Road
Simapu Town
Shantou Shi
Guangdong Sheng , 515000
ChinaFEI 3016825286Issued Jan 28, 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 3016825286.
Violations3
Issue DateJan 28, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Shantou Kangjie Daily Chemical Industry Co., Ltd
Location
Fang Yongliang
Manager
Shantou Kangjie Daily Chemical Industry Co., Ltd
Kangjie Company, Xiangang Road
Simapu Town
Shantou Shi
Guangdong Sheng , 515000
China
FEI Number
3016825286
Country
China
Issue Date
January 28, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Shantou Kangjie Daily Chemical Industry Co., Ltd, a Chinese manufacturer of over-the-counter drug products including hand sanitizer, failed to conduct identity testing on incoming raw materials before releasing them for use in manufacturing, violating 21 CFR 211.84(d)(1). The facility did not demonstrate adequate testing protocols to verify the identity of each component in its drug products, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act. The warning was issued on January 28, 2025, following FDA's review of records submitted in response to a March 2024 information request.
Shantou Kangjie Daily Chemical Industry Co., Ltd FDA Warning Letter, January 28, 2025
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