Valley Springs Artesian Gold LLC – FDA Warning Letter, Jun 30, 2008
On June 23, 25, 27, and 30, 2008, an FDA inspection of Valley Springs Artesian Gold LLC's bottled water facility revealed deviations from 21 CFR Part 129, rendering products adulterated under 21 U.S.C. § 342(a)(4). The Form FDA 483 listed nine violations.
The firm failed to retain current government approvals for product and operations water sources (21 CFR 129.80(h)). Microbiological testing of source water, obtained from a non-public system, was not conducted weekly (21 CFR 129.35(a)(3)(i)). Annual chemical and quadrennial radiological testing of source water were also deficient (21 CFR 129.35(a)(3)(i)).
Regarding product testing, the firm failed to perform weekly bacteriological testing of bottled water (21 CFR 129.80(g)(1)) and annual chemical, physical, and radiological testing for each bottled water type (21 CFR 129.80(g)(2)).
Facility issues included the bottling room not being separated from storage or the loading dock (21 CFR 129.20(a)), and inadequate ventilation causing condensation over the filling line (21 CFR 129.20(
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