Ningbo Riway Industrial Co., Ltd.

Warning LetterOpen

Mr. David Duan General Manager Ningbo Riway Industrial Co., Ltd. No. 555 Binhai Avenue Building E1, Binhai Wanyang Creative City Binhai New Area, Economic Development Zone Fenghua Shi Ningbo Shi Zhejiang Sheng , 315524FEI 3016905536Issued Apr 30, 2025Center 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 3016905536.

Violations5

Issue DateApr 30, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Ningbo Riway Industrial Co., Ltd.
Location: Mr. David Duan General Manager Ningbo Riway Industrial Co., Ltd. No. 555 Binhai Avenue Building E1, Binhai Wanyang Creative City Binhai New Area, Economic Development Zone Fenghua Shi Ningbo Shi Zhejiang Sheng , 315524
FEI Number: 3016905536
Country: China
Issue Date: April 30, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Ningbo Riway Industrial Co., Ltd., a Chinese manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drugs that did not conform to required manufacturing, processing, packing, and holding standards. Two specific products—KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES—were identified as unapproved new drugs introduced into interstate commerce and were also misbranded in violation of federal law. The violations were identified following FDA's review of records submitted by the company in response to a March 11, 2024 information request.

Ningbo Riway Industrial Co., Ltd. FDA Warning Letter, April 30, 2025