DNE Nutraceuticals Inc. – FDA Warning Letter, Mar 11, 2013

The FDA issued a Warning Letter to DNE Nutraceuticals, Inc. following an inspection from February 19 to March 11, 2013, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. These violations render their dietary supplement products adulterated under 21 U.S.C. 342(g)(1) due to non-compliance with 21 CFR Part 111 (CGMP for dietary supplements). Additionally, products like (b)(4) are misbranded under 21 U.S.C. 343.

Key CGMP violations include: 1. **Failure to establish specifications:** No specifications for in-process production, finished products, or documentation for their basis (21 CFR 111.70). 2. **Lack of identity testing for dietary ingredients:** No tests performed to verify the identity of dietary ingredients before use (21 CFR 111.75(a)(1)(i)). 3. **Failure to confirm identity of other components:** No documentation for qualifying suppliers or confirming non-dietary component identity (21 CFR 111.75(a)(2)). 4. **Absence of Master Manufacturing Records (MMRs):** No written MMRs for unique formulations or batch sizes, and draft MMRs were inadequate (21 CFR 111.20