Dakota Pure Water, Inc. – FDA Warning Letter, Jun 6, 2011

On June 3 and 6, 2011, an FDA inspection of Dakota Pure Water, Inc.'s bottled water manufacturing facility in Fargo, North Dakota, revealed violations of 21 CFR Part 129 (Bottled Drinking Water Regulations) and 21 CFR Part 110 (Current Good Manufacturing Practice for foods). These violations render the product adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include: 1. Failure to conduct weekly bacteriological sampling of bottled water products since April 30, 2009, as required by 21 CFR 129.80(g)(1). 2. Failure to conduct annual chemical, physical, and radiological analysis of bottled water products since April 30, 2009, as required by 21 CFR 129.80(g)(2). This was also noted in a previous April 2009 inspection. 3. Failure to store toxic chemicals to prevent contamination of food, food-contact substances, or packaging materials, as required by 21 CFR 110.35(b)(2), evidenced by open containers of household chemicals in the production area. 4. Failure to provide running water at a suitable temperature in hand-washing facilities, as required by 21 CFR 1