N.V.E. Pharmaceuticals, Inc. – FDA Warning Letter, Sep 26, 2012

On July 22, 2013, the FDA issued a Warning Letter to N.V.E. Pharmaceuticals, Inc. following an inspection from September 11-26, 2012, which revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). These violations caused their dietary supplement products to be adulterated under 21 U.S.C. § 342(g)(1). The FDA also determined several products were misbranded under Section 403 of the Act.

Key CGMP violations included: 1. Failure to establish required specifications for components and finished products (21 CFR 111.70). 2. Failure to conduct identity testing for dietary ingredient components prior to use (21 CFR 111.75(a)(1)(i)). 3. Failure to prevent contamination during manufacturing and use sanitary handling procedures, with observations of residue, dust, and unprotected products/materials (21 CFR 111.365, 21 CFR 111.415(c)). 4. Failure to use properly maintained equipment, with observations of torn tubes, taped equipment, and product residue (21 CFR 111.27(a)). 5. Inadequate product complaint procedures, lacking details for documentation, review