FDA WARNING_LETTER - DNG Trading & Milling, LLC - December 12, 2013

The FDA inspected DNG Trading & Milling, LLC's dietary supplement manufacturing facility in Skaneateles, NY, from November 20 to December 12, 2013, finding serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render their contract-manufactured dietary supplements adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, several products are misbranded under Section 403 of the Act.

Key violations include: 1. **Failure to establish finished product specifications:** The firm lacked specifications for identity, purity, strength, and composition (21 CFR 111.70(e)). Their existing specifications were inadequate. 2. **Inadequate identity testing of dietary ingredients:** The firm did not conduct appropriate, scientifically valid tests to verify the identity of dietary ingredients, relying on insufficient organoleptic methods like visual inspection of color (21 CFR 111.75(a)(1)(i), 111.75(h)(1)). 3. **Deficiencies in Master Manufacturing Records (MMR):** MMRs lacked statements of expected yield percentages, representative labels (or cross-references), and procedures for sampling (21 CFR 111.210). 4. **Failure to review and