FDA WARNING_LETTER - Creekside Springs LLC - July 12, 2011

The FDA inspected Creekside Springs, LLC's bottled water facility in Salineville, Ohio, on multiple dates in June and July 2011, finding violations of the Processing and Bottling of Bottled Drinking Water Regulation (21 CFR Part 129). Consequently, the firm's spring, drinking, and distilled water products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under unsanitary conditions. Observed violations included inadequate ventilation in the bottling room leading to condensation (21 CFR 129.20(c)), failure to keep product water-contact surfaces clean and sanitized (21 CFR 129.37(a)), and failure to retain current water source approval certificates at the plant (21 CFR 129.80(h)). Additionally, the firm failed to adequately clean, sanitize, and inspect multiservice primary containers (21 CFR 129.80(b)(1)), handle single service containers sanitarily (21 CFR 129.37(c)), and ensure ozone treatment complied with regulations (21 CFR 129.80(a)). The firm's October 4, 2011, response was inadequate, lacking documentation or sufficient procedural details for proposed corrections. Creekside Springs must take prompt action to correct all violations and prevent recurrence, submitting a written response within fifteen working days with supporting documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.