FDA WARNING_LETTER - Anti L’Age - October 07, 2024

The FDA conducted an inspection of Dr. Arash Mohrdar's facility at 6086 Brockton Ave, Riverside, CA, from September 17 to October 4, 2024. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations, specifically Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the dietary supplement products manufactured at the facility, including ESR Amino, Transfer Factor C, and Heart Amino, adulterated under section 402(g)(1) of the Act.

Key violations include: 1. Failure to establish finished product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.70(e)). 2. Failure to establish component specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.70(b)). 3. Failure to establish specifications for dietary supplement labels and packaging (21 CFR 111.70(d)). 4. Failure to prepare and follow written master manufacturing records (21 CFR 111.205). 5. Failure to prepare batch production records for each batch manufactured (21 CFR 111.255(a)). 6. Failure to establish and follow written procedures for quality control operations (21 CFR