DYNAMIC TECHNICAL FORMULATIONS LLC – FDA Warning Letter, Jun 16, 2017

The FDA issued a Warning Letter to Mr. Wotiz following an inspection of his facility in Roswell, GA, from May 25 to June 16, 2017. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, DTF, Gym Candy, and Biotech Underground products were found to be misbranded due to labeling violations.

A critical finding was that the product Tri-ton, marketed as a dietary supplement, contained ostarine and andarine (SARMs), classifying it as an unapproved new drug and misbranded drug. The firm voluntarily recalled Tri-ton in May 2017, but the FDA emphasized significant safety concerns, including potential for liver toxicity, heart attack, and stroke.

Key CGMP violations included: 1. Failure of quality control personnel to ensure product quality and proper packaging/labeling, and lack of qualified quality control personnel (21 CFR 111.105, 111.12(c), 111.103, 111.65). 2. Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205). 3. Failure to prepare Batch Production Records for manufactured dietary supplements (2