Abba Pharma Inc. – FDA Warning Letter, Aug 30, 2010

On February 9, 2011, the FDA issued a Warning Letter to Abba Pharma, Inc. following an inspection from August 9-30, 2010. The inspection revealed that "Proteinex® Liquid Predigested Protein" (15 and 18 GRAMS, 100 Calories) and "Proteinex® Wound Care" products were misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(l)]. Laboratory analysis showed that the actual amounts of phosphorus, sodium, and potassium in these products were significantly higher than declared on their labels.

Additionally, the dietary supplement "Nephronex Liquid Dietary Supplement" was found to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] due to serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). Specific CGMP violations included: 1. Failure to conduct finished product testing for identity, purity, strength, and composition (21 CFR 111.75(c)). 2. Failure to establish product specifications for finished dietary supplement batches (21 CFR 111.95(b