Furley Bioextracts SDN BHD Warning Letter Details

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.