Nantong Furuida Packaging Products Co., Ltd.

Warning LetterOpen

Mr. Sunan Ge Site Manager Nantong Furuida Packaging Products Co., Ltd. No 1, Guoyuan Cun, Wenfeng Street Chongchuan Qu Nantong Shi Jiangsu Sheng , 226004 ChinaFEI 3015509579Issued Nov 17, 2023Center 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 3015509579.

Violations2

Issue DateNov 17, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nantong Furuida Packaging Products Co., Ltd.
Location: Mr. Sunan Ge Site Manager Nantong Furuida Packaging Products Co., Ltd. No 1, Guoyuan Cun, Wenfeng Street Chongchuan Qu Nantong Shi Jiangsu Sheng , 226004 China
FEI Number: 3015509579
Country: China
Issue Date: November 17, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Nantong Furuida Packaging Products Co., Ltd., an OTC drug manufacturer in China, failed to conduct required testing of active pharmaceutical ingredients (APIs) for identity and conformity with specifications for purity, strength, and quality as mandated by CGMP regulations. The company released APIs for manufacturing based solely on supplier certificates of analysis without qualifying suppliers or verifying the information provided, and did not demonstrate testing of incoming raw material lots, including methanol testing for isopropyl alcohol. These manufacturing and control failures rendered the firm's drug products adulterated under federal law.

Nantong Furuida Packaging Products Co., Ltd. FDA Warning Letter, November 17, 2023