FDA WARNING_LETTER - Muscle Feast, LLC - January 04, 2022

The FDA conducted an inspection of Muscle Feast, LLC, located at 1320 Boston Road, Nashport, OH, from December 13-15, 2021, to January 3-4, 2022. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish identity specifications for components like caffeine anhydrous and whey protein isolate (21 CFR 111.70(b)(1)). The provided response was inadequate, as HPLC identification lacked specific methods or reference standards. 2. Failure to establish component specifications for purity, strength, and composition (21 CFR 111.70(b)(2)). 3. Failure to establish finished product specifications for identity, purity, strength, and composition (21 CFR 111.70(e)). Visual and organoleptic attributes were deemed insufficient for powdered products. 4. Quality control personnel failed to approve or reject processes, specifications, and deviations (21 CFR 111.105(a)), specifically regarding calibration log entries. 5. Quality control personnel failed to review and approve all batch production records (BPR