Furley Bioextracts SDN BHD

Warning LetterOpen

Mr. Stuart Soo Managing Director Furley Bioextracts SDN BHD No. 7, Jalan Villaraya, Villaraya Industrial Park 3 23rd Mile, Jalan Sungai Lalang 43500 Semenyih Selangor MalaysiaFEI 3008174509Issued Sep 13, 2021Center for Drug Evaluation and Research | CDER

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Violations6

Issue DateSep 13, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Furley Bioextracts SDN BHD
Location: Mr. Stuart Soo Managing Director Furley Bioextracts SDN BHD No. 7, Jalan Villaraya, Villaraya Industrial Park 3 23rd Mile, Jalan Sungai Lalang 43500 Semenyih Selangor Malaysia
FEI Number: 3008174509
Country: Malaysia
Issue Date: September 13, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Furley Bioextracts SDN BHD, a Malaysian manufacturer of over-the-counter drug products, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products that did not conform to required specifications. The company failed to conduct appropriate laboratory testing to verify that each batch of PainFix Relief Gel met final specifications for identity and strength of active ingredients prior to release, in violation of 21 CFR 211.165(a). Additionally, PainFix Relief Gel was distributed as an unapproved new drug and misbranded product in interstate commerce, violating sections 505(a) and 502(ee) of the Federal Food, Drug, and Cosmetic Act. The FDA issued this warning letter on September 13, 2021, following a records request made in November 2020.

Furley Bioextracts SDN BHD FDA Warning Letter, September 13, 2021