FDA WARNING_LETTER - Prolifix Nutrition, LLC - February 15, 2019

On February 11-15, 2019, the FDA inspected a facility in Hurricane, Utah, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the dietary supplement products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish finished product specifications for identity, purity, strength, composition, and contaminant limits (21 CFR 111.70(e)). 2. Failure to establish adequate component specifications for purity, strength, and composition, and insufficient identity testing (21 CFR 111.70(b), 111.75(a)(1)(i), 111.75(a)(2)). 3. Quality control personnel failed to approve or reject processes, specifications, procedures, controls, tests, and deviations (21 CFR 111.105(a)). 4. Batch production records lacked complete information (21 CFR 111.255(b), 111.260). 5. Lack of control over label issuance and use (21 CFR 111.410(b)). 6. Failure to document equipment maintenance, cleaning, sanitizing, and