Soluble Products Co., LP – FDA Warning Letter, Aug 12, 2010

On August 2-12, 2010, the FDA inspected Soluble Products Co., LP's dietary supplement manufacturing facility in Lakewood, New Jersey, finding serious violations of 21 CFR Part 111, cGMP for Dietary Supplements. These violations render their dietary supplements adulterated under section 402(g)(1) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. Failure to establish component identity specifications for components used in several "Revival Soy Pro Water Mix" dietary supplements (21 CFR 111.70(b)(1)). 2. Master Manufacturing Records (MMR) for "Revival Brand Unsweetened Chocolate" (lot 10 11 RUCA5) lacked required information, including identity/weight of ingredients, expected yield, packaging description/label, and specifications for manufacturing process control (21 CFR 111.210). 3. Failure to verify finished dietary supplement batches meet product specifications for identity, purity, strength, and composition, specifically for "Revival Brand Unsweetened Chocolate" (lot 10 11RUCA5) (21 CFR 111.75(c)). 4. Failure to establish specifications for products received from suppliers for packaging/labeling and distribution, specifically for 8-count multivitamin blister packs (21 CFR 11