Furley Bioextracts SDN BHD – FDA Warning Letter, May 7, 2021

The FDA issued Warning Letter 320-21-56 to Furley Bioextracts SDN BHD on September 13, 2021, following a review of records submitted in response to a November 5, 2020, request. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products, including PainFix Relief Gel, adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to conduct adequate finished drug product testing (21 CFR 211.165(a))**: The firm did not perform identity and strength testing for menthol in PainFix Relief Gel. Required actions include providing chemical and microbial specifications, an action plan for testing retain samples, a summary of results, and an independent assessment of laboratory practices. 2. **Failure to test incoming components for identity and conformity (21 CFR 211.84(d)(1))**: The firm did not test incoming active pharmaceutical ingredients (APIs) for identity. Required actions include an independent review of the material system, chemical and microbiological specifications for components, a description of component testing, and a summary of COA validation. 3. **Failure to support expiration dates with stability testing (2