FDA WARNING_LETTER - Nexagen, LLC - April 07, 2017

On April 3-7, 2017, the FDA inspected facilities at 630 Highway 314, Ste. 1011, Fayette, GA 30214 and 115 Bethea Road, Ste. 203, Fayetteville, GA 30214, revealing significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the manufactured dietary supplements adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review, disposition decisions, and reprocessing approval (21 CFR 111.103). 2. Failure to establish specifications for manufacturing processes, components, in-process production, labels, packaging, and finished product identity, purity, strength, and composition (21 CFR 111.70(a)-(e), (g)). 3. Master Manufacturing Records (MMRs) for several products lacked required specifications, sampling procedures, specific actions, and corrective action plans (21 CFR 111.205(b)(1), 111.210(h)). 4. Batch Production Records (BPRs) were incomplete, missing equipment identity and