FDA WARNING_LETTER - InnoMark, Inc. - March 15, 2023

The FDA issued a Warning Letter to Mr. Moody following an inspection of their facility at 4041 S. River Rd., Saint George, Utah, from March 8-15, 2023. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, specifically regarding Current Good Manufacturing Practice (cGMP) for dietary supplements (21 CFR Part 111) and labeling requirements.

The dietary supplements (b)(4) and (b)(4) sticks were deemed adulterated due to cGMP violations. Key deficiencies included: 1. **Failure to establish finished product specifications** for strength and composition (21 CFR 111.70(e)). 2. **Failure to establish component specifications** for strength and composition of ingredients (21 CFR 111.70(b)(2)). The firm's response regarding third-party testing and vendor COAs was deemed inadequate without evidence. 3. **Failure to verify identity of dietary ingredients** through appropriate testing; the FTIR instrument was broken since June 2021 (21 CFR 111.75(a)(1)(i)). Corrective actions lacked evidence of implementation. 4. **Failure to confirm components meet contamination limits** and qualify suppliers when relying on COAs (21 CFR 111.75(a)(2)). Supplier COAs lacked required test results. 5