Armada Nutrition – FDA Warning Letter, Mar 24, 2017

On August 1, 2017, the FDA issued a Warning Letter to Armada Nutrition LLC following an inspection from March 13-24, 2017, at their Spring Hill, Tennessee facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated under Section 402(g)(1) of the Federal Food Drug and Cosmetic Act.

Key violations included: 1. **Failure to establish and follow written procedures for laboratory operations (21 CFR 111.303):** The firm lacked SOPs for tests conducted using their (b)(4) and (b)(4) for identity testing. Their response, stating SOPs would be completed by October 1, 2017, was deemed inadequate as it didn't address interim measures. 2. **Failure to calibrate instruments and controls (21 CFR 111.27(b)):** The (b)(4) used for identity testing had not been calibrated since July 2016. The firm's response about establishing purchase orders for calibration was insufficient without documentation of interim calibration plans. 3. **Failure to prevent contamination during manufacturing (21 CFR 111.365(a)):** Investigators observed an employee vacuuming the floor and then using the same nozzle