ShangRao Chunyu Technology Co., Ltd.

Warning LetterOpen

Mr. Daniel Suer CEO ShangRao Chunyu Technology Co., Ltd. Xuri Zone Shangrao Economic-Technical Development Area Shangrao Shi Jiangxi Sheng , 334100 ChinaFEI 3015958566Issued Feb 3, 2021Center for Drug Evaluation and Research | CDER

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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 3015958566.

Violations2

Issue DateFeb 3, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: ShangRao Chunyu Technology Co., Ltd.
Location: Mr. Daniel Suer CEO ShangRao Chunyu Technology Co., Ltd. Xuri Zone Shangrao Economic-Technical Development Area Shangrao Shi Jiangxi Sheng , 334100 China
FEI Number: 3015958566
Country: China
Issue Date: February 03, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

ShangRao Chunyu Technology Co., Ltd. manufactured an antiseptic hand sanitizer product labeled as containing 75% ethanol that was found to contain only 58% ethanol when tested by FDA at the U.S. border. The subpotent product violated Current Good Manufacturing Practice (CGMP) requirements, demonstrating that the company's quality assurance procedures were not functioning adequately to ensure the strength, purity, and quality of finished pharmaceuticals. The batch was detained and refused admission into the United States due to these adulteration violations under sections 501(a)(2)(B) and 501(c) of the Federal Food, Drug, and Cosmetic Act.

ShangRao Chunyu Technology Co., Ltd. FDA Warning Letter, February 3, 2021