FDA EIR - DS Waters of America, Inc. - December 28, 2009

An FDA inspection of AquaOne, Inc. in Orem, UT, was conducted from December 2 to December 28, 2009. This comprehensive general sanitation food inspection, initiated under the Domestic Food Safety Program (CP 7303.803) and the Nutrition Labeling and Education Act (CP 7321.005), focused on the company's operations as a manufacturer of distilled, fluoridated, and drinking water, and its services in maintaining and distributing water coolers.

The primary issues identified, citing 21 CFR 129.40(a)(1) concerning plant equipment and operations, revolved around AquaOne's significant non-adherence to equipment manufacturers' recommendations. Specifically, the inspection revealed multiple instances where the firm failed to: replace filters at recommended frequencies, conduct required cleaning procedures for various equipment, replace specific parts as recommended, and perform routine inspections and maintenance as outlined in operation manuals. These recurring omissions across different pieces of equipment suggest a systemic issue in following established operational guidelines crucial for maintaining product quality and safety, particularly within the water purification process. The implied required actions necessitate that AquaOne rigorously implement and consistently follow all manufacturer-specified maintenance, cleaning, part replacement, and inspection protocols to rectify these deficiencies and achieve regulatory compliance.