Nuvonyx, Inc. – FDA Warning Letter, Jan 20, 2011

On October 18-21, 2010, and January 10-20, 2011, the FDA inspected Nuvonyx, Inc. DBA Real Aloe, Inc. and U.S. Aloe in Carlsbad, CA, a manufacturer of dietary supplements. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering dietary supplements AloeAdvanced and AloeControl adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act. An FDA-483 was issued on October 21, 2010, and violations remained uncorrected during the January 2011 inspection.

Violations include: 1. Failure to conduct appropriate finished batch testing for identity, purity, strength, and composition (21 CFR 111.75(c)). 2. Failure to establish component specifications for dietary supplements (21 CFR 111.70(b)(1) and (b)(2)). 3. Failure to conduct identity testing for dietary ingredients prior to use, relying instead on supplier Certificates of Analysis (COAs) (21 CFR 111.75(a)(1)(i)). 4. Failure to qualify non-dietary ingredient suppliers by confirming COA results (21 CFR 111.75(a