CocoKefir, LLC – FDA Warning Letter, May 15, 2012

On November 6, 2012, the FDA issued a Warning Letter to CocoKefir, LLC, following an inspection from May 4-15, 2012, at their Medina, Minnesota facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering their Tula’s CocoKefir, Tula’s Citrus CocoKefir, and Tula’s Apple Cinnamon CocoKefir products adulterated. The FDA also noted that the products' labeling as "beverages," "nature's sports drink," and "probiotic drink" suggests they are conventional foods, which would misbrand them if simultaneously labeled as dietary supplements.

Key violations included: - Failure to prepare and follow written master manufacturing records (21 CFR 111.205(a)). - Failure to establish product specifications for finished dietary supplements (21 CFR 111.70(e)). - Failure to establish identity and component specifications for dietary ingredients (21 CFR 111.70(b)(1), (2), (3)). - Failure to conduct identity testing on incoming dietary ingredients (21 CFR 111.75(a)(1)(i)). - Failure to establish and follow written procedures for quality control operations (21 CFR 111.1