FDA EIR - Magnetic Springs Water Company - September 30, 2013

An FDA inspection of Magnetic Springs Water Company, a bottled drinking water plant, was conducted from September 20-30, 2013, to assess compliance with 21 CFR Part 129 (Bottled Water) and 21 CFR Part 110 (Current Good Manufacturing Practices). The inspection identified several deviations documented in a Form FDA-483 with nine observations and three discussion items.

Key issues included a finished spring water sample exceeding the allowable limit for bromate, and bacteriological samples not being collected as primary product containers. The company failed to regularly test the concentration of cleaning and sanitizing solutions used on equipment and in the bottle washer. Furthermore, basic hygiene requirements were not met, such as the absence of hand drying facilities in the men's restroom, no soap in the women's restroom, and a lack of hand washing signs at sinks.

Operational deficiencies involved not visually inspecting finished products to ensure proper coding before storage, and inadequate analysis of water samples to confirm the uniformity and effectiveness of treatment processes, particularly ozone. There was also a lack of documentation for daily physical inspections of plant equipment. Additional concerns included infrequent bacteriological swab sampling of containers and caps, and no records of ozonated water contact time for sanitizing filler nozzles.

The regional manager committed to correcting all identified deviations. Immediate actions included providing soap and arranging for hand drying supplies in restrooms, and obtaining new samples for bromate testing. The company also plans to address sampling procedures with their laboratory and enhance monitoring of their ozone treatment process. The FDA provided guidance documents and emphasized the need for a written recall procedure.