Guangzhou Minghui Cosmetics Co., Ltd.

Warning LetterOpen

Mr. Biao Chen General Manager Guangzhou Minghui Cosmetics Co., Ltd. No. 1, Dongchang Road Donghua Industrial Zone Renhe Town, Baiyun Guizhou Sheng , 510470 ChinaFEI 3016753019Issued Jul 6, 2021Center for Drug Evaluation and Research

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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 3016753019.

Violations5

Issue DateJul 6, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Guangzhou Minghui Cosmetics Co., Ltd.
Location: Mr. Biao Chen General Manager Guangzhou Minghui Cosmetics Co., Ltd. No. 1, Dongchang Road Donghua Industrial Zone Renhe Town, Baiyun Guizhou Sheng , 510470 China
FEI Number: 3016753019
Country: China
Issue Date: July 06, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Guangzhou Minghui Cosmetics Co., Ltd. was cited for manufacturing Qi Yu® Hand Sanitizer Gel, an unapproved new drug that was adulterated and misbranded, with FDA laboratory testing revealing the product's active ingredient strength fell below labeled claims. The company's quality assurance and current good manufacturing practice (CGMP) controls were found to be inadequate, as evidenced by the subpotent batch detected during a border detention and refusal of admission. The product violated multiple sections of the Federal Food, Drug, and Cosmetic Act, including prohibitions on introducing unapproved new drugs into interstate commerce and misbranding requirements.

Guangzhou Minghui Cosmetics Co., Ltd. FDA Warning Letter, July 6, 2021