FDA WARNING_LETTER - Reed's Inc - November 12, 2010

On October 27, 2010, through November 12, 2010, the FDA inspected Reed's Inc.'s manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (cGMP) for dietary supplements (21 CFR Part 111), causing Reed's Nausea Relief dietary supplement products to be adulterated. Additionally, the Reed's Natural Energy Elixir product was found to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and food labeling regulations (21 CFR Part 101).

Key violations include: 1. **Dietary Supplement cGMP Violations:** * Failure to establish in-process and finished product specifications for Reed's Nausea Relief (21 CFR 111.70). * Failure to conduct identity testing for dietary ingredients (ginger, Vitamin B3, B6, B12) in Reed's Nausea Relief, relying solely on supplier Certificates of Analysis (21 CFR 111.75(a)(1)). * Batch production records for Reed's Nausea Relief lacked required information, including batch/lot numbers, equipment identity, cleaning/sanitizing dates, unique component identifiers, identity/weight of components (e.g., water), actual/theoretical yield, and documentation of manufacturing steps with initials (21 CFR 11