Guangzhou Zhongkebaishi Health Industry Co., Ltd.

Warning LetterOpen

Mr. Shaoshan Chen Sales Manager Guangzhou Zhongkebaishi Health Industry Co., Ltd. Floor 2C, No. 1, Fengying Fourth Rd, High Tech Industrial Conghua Qu Guangzhou Shi Guangdong Sheng , 510990 ChinaFEI 3016706196Issued Apr 19, 2022Center for Drug Evaluation and Research | CDER

View Letter

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 3016706196.

Violations5

Issue DateApr 19, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Guangzhou Zhongkebaishi Health Industry Co., Ltd.
Location: Mr. Shaoshan Chen Sales Manager Guangzhou Zhongkebaishi Health Industry Co., Ltd. Floor 2C, No. 1, Fengying Fourth Rd, High Tech Industrial Conghua Qu Guangzhou Shi Guangdong Sheng , 510990 China
FEI Number: 3016706196
Country: China
Issue Date: April 19, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Guangzhou Zhongkebaishi Health Industry Co., Ltd. was cited for manufacturing Hand Sanitizer Gel that failed FDA laboratory testing and was detained at the U.S. border. The product violated the Federal Food, Drug, and Cosmetic Act as an unapproved new drug that was adulterated due to subpotency (falling below represented strength, purity, or quality), misbranded, and manufactured without adequate quality assurance systems compliant with Current Good Manufacturing Practice (CGMP) requirements. The violations included failure to maintain proper manufacturing controls and quality standards required for pharmaceutical products intended for introduction into U.S. interstate commerce.

Guangzhou Zhongkebaishi Health Industry Co., Ltd. FDA Warning Letter, April 19, 2022