Universal Supplement, Inc. – FDA Warning Letter, Jul 29, 2011

On July 14-29, 2011, the FDA inspected Universal Supplement, Inc.'s dietary supplement manufacturing facility, identifying significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). These violations render Bee Pollen, Night Rinse, Male Formula, and Propolis products adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to follow Master Manufacturing Records (MMRs):** Propolis (USI# 4329) was manufactured with an incorrect ingredient, and no recall documentation was provided. (21 CFR 111.205(a)) 2. **Lack of component identity testing:** No identity verification tests were conducted for dietary ingredients in Male Formula (USI# 4261), Propolis (USI# 4329), and Night Rinse capsules (USI# 4346). (21 CFR 111.75(a)(1)) 3. **Failure to establish specifications:** No component or finished product specifications were established for Male Formula, Propolis, and Night Rinse capsules. (21 CFR 111.70(b), 111.70(e)) 4. **Incomplete MMRs:** MMRs for Night Rinse, Male Formula