FDA WARNING_LETTER - Absonutrix, LLC - March 22, 2019

The FDA conducted an inspection of Absonutrix's manufacturing facility in Greensboro, NC, from March 18-22, 2019, and reviewed product labeling. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act, rendering their dietary supplements adulterated and misbranded.

Key violations include: 1. **Adulterated Dietary Supplements (21 CFR Part 111 - CGMP):** * Failure to verify the identity of dietary ingredients (e.g., (b)(4) and (b)(4)) prior to use, a repeat observation. * Failure to prepare and follow written Master Manufacturing Records (MMRs) for unique formulations and batch sizes, and incomplete MMRs for products like Uridine, NAD Power Booster, and Lions Mane Mushroom Extract. * Failure to include complete information in Batch Production Records (BPRs), such as equipment identity, cleaning dates, unique component identifiers, and documentation of manufacturing and quality control, also a repeat observation. * Failure to make and keep documentation of calibrations for instruments and controls used in manufacturing or testing, a repeat observation.

2. **Misbranded Dietary Supplements (21 CFR Part 101 - Labeling):** * False and misleading labeling regarding dietary ingredient amounts for Absonutrix Uridine 500 mg, Absonutrix Lions Mane Mushroom Extract,