FDA EIR - SweetSommer Water Bottling Company, LLC. - September 22, 2009

An FDA inspection of SweetSommer Water Bottling Company, LLC, conducted from September 15-22, 2009, revealed significant deviations from federal bottled water regulations, specifically 21 CFR 110, 129, and 165. The firm received a 12-item FDA-483 for numerous issues.

Key violations included a severe lack of comprehensive production and equipment maintenance records, particularly for periods prior to March 2009. The company consistently failed to perform required weekly microbiological testing on both source and finished product water and did not adequately address analytical results showing elevated levels of iron and aluminum. Critical sanitation concerns were noted, such as dead mice, salamanders, a frog, and rodent nesting material found within spring water housings, and missing paint with rusty nails in the water reservoir. Additionally, the facility's bottling operations lacked adequate separation from packaging, potentially risking contamination. The firm did not conduct all mandated chemical tests, omitting dioxin, diquat, endothall, and glyphosate. Management also admitted to having no formal employee training program and inadequate recall procedures, as they could not trace specific product lots to customers.

During the inspection close-out, SweetSommer Water Bottling Company leadership offered no immediate corrective commitments. The State of West Virginia initiated an embargo on all products and requested a voluntary consumer-level recall.