FDA WARNING_LETTER - Seven - August 19, 2019

The FDA inspected a facility at 1420 Decision St., Ste. C, Vista, CA, on August 12-13, 15, and 19, 2019, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render the manufactured dietary supplements adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to establish specifications (21 CFR 111.70):** * No component specifications for identity, purity, strength, and composition for products like Male Formula Blend, Energy Veg, and Total Cleanse (21 CFR 111.70(b)). * No specifications for dietary supplement labels and packaging that contact products (21 CFR 111.70(d)). * No finished product specifications for identity, purity, strength, and composition, or contaminant limits (21 CFR 111.70(e)), observed for Male Formula Blend. The firm's response was deemed inadequate as it lacked comprehensive specifications for all products.

2. **Failure to prepare and follow written Master Manufacturing Records (MMRs) (21 CFR 111.205(a)):** * No MMR