FDA WARNING_LETTER - Paks Clothiers (dba) Aqua Pure Drinking Water - April 13, 2015

On September 30, 2015, the FDA issued a Warning Letter to Paks Clothiers, Inc., DBA Aqua Pure Drinking Water, following an inspection from April 6-13, 2015. The inspection revealed serious violations of 21 CFR Part 129, rendering their bottled water products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: * **Microbiological Testing (21 CFR 129.80(g)(1)):** Failure to analyze weekly samples for coliforms, with only two samples taken between October 2014 and April 2015. Detected coliforms were not quantified, and E. coli testing was not performed when coliforms were present. * **Container Sanitation (21 CFR 129.80(f)):** One five-gallon container yielded coliforms, failing the requirement for multiuse containers to be free of coliforms. Rinse count sampling was infrequent (twice between January 2013 and April 2015), and no bacteriological swab or rinse count tests were performed on closures. * **Cleaning/Sanitizing Solution Monitoring (21 CFR 129.80(c)):** Failure to sample and test cleaning/sanitizing solutions or