What happened
Original notice title
Dynamic Technical Formulations 12/13/17
From the archived source record
The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations render your dietary supplements adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)], in that the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your DTF, Gym Candy, and Biotech Underground products misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)]. We acknowledge that your firm voluntarily recalled Tri-ton in May 2017; this letter emphasizes significant safety concerns about Tri-ton, which is marketed as a dietary supplement but is actually an unapproved new drug and misbranded drug. Life-threatening reactions have occurred with the use of SARMs, including liver toxicity. SARMs also have the potential to increase the risk of heart attack and stroke. Dietary Supplement CGMP Violations The significant violations of dietary supplement CGMP requirements identified during the May 25 to June 16, 2017, inspection include, but may not be limited to, the following: 1. Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control. Your response also does not address our concerns regarding your ensuring that the quality control unit consists of personnel qualified through education, training, or experience to perform the necessary duties or provide adequate evidence of their implementation.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 8a3449ad9062
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →