Xiamen Wally Bath Manufacture Co., Ltd.

Warning LetterOpen

Mr. Jackson Zhong Xiamen Wally Bath Manufacture Co., Ltd. 4F, No.217, Tianfeng Road, Northern Industry Jimei Qu Xiamen Shi Fujian Sheng , 361021 ChinaFEI 3009675687Issued Nov 15, 2023Center 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 3009675687.

Violations4

Issue DateNov 15, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Xiamen Wally Bath Manufacture Co., Ltd.
Location: Mr. Jackson Zhong Xiamen Wally Bath Manufacture Co., Ltd. 4F, No.217, Tianfeng Road, Northern Industry Jimei Qu Xiamen Shi Fujian Sheng , 361021 China
FEI Number: 3009675687
Country: China
Issue Date: November 15, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Xiamen Wally Bath Manufacture Co., Ltd., an OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to conduct identity testing on incoming raw materials, instead relying solely on supplier certificates of analysis, and did not test incoming ethanol lots for methanol content or establish specifications for allowable methanol limits. These violations of 21 CFR 211.84(d)(1) were identified through FDA's review of records submitted in response to section 704(a)(4) requests made in June and July 2022.

Xiamen Wally Bath Manufacture Co., Ltd. FDA Warning Letter, November 15, 2023