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

On January 19, 2010, the FDA issued a Warning Letter to SweetSommer Water Bottling Company, LLC, following an inspection from September 15-22, 2009. The inspection revealed serious violations of 21 CFR Part 129, rendering their bottled water adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Microbiological Testing Deficiencies:** Failure to weekly sample and analyze source water for microbiological contaminants (21 CFR 129.35(a)(3)(i)). In 2008, only 7 weeks of records existed for at least 18 weeks of production, with only one instance of individual spring testing. In 2009, only 1 week of records existed for 15 weeks of production. 2. **Unsafe Source Water:** Failure to establish safe and sanitary source water quality (21 CFR 129.35(a)(1)). Source water tests in 2008 and 2009 showed coliforms and E. coli, with no documented review or corrective actions. 3. **Finished Product Testing Deficiencies:** Failure to weekly sample and analyze finished bottled water for bacteriological purposes (21 CFR 129.80(g