FDA EIR - DS Services of America - June 21, 2011

Deep Rock Water Company in Grand Junction, CO, underwent a routine FDA inspection from June 20-21, 2011, focusing on its bottled water operations under the Domestic Food Safety Inspection Program. The inspection identified several critical issues, leading to the issuance of an FDA-483, Inspectional Observations, to General Manager Mr. Gary W. Nadel. The main violation was that finished artesian bottled water did not comply with quality standards, exhibiting a bromate level of 20 micrograms per milliliter, double the FDA's allowable limit of 10 micrograms per milliliter (referencing 21 CFR 129.35(a)(4)(iv)). Management committed to initiating bimonthly bromate testing to address this. Additionally, the company failed to maintain required sampling and analysis records on-site, with coliform testing records for a period in early 2011 being absent (pertaining to 21 CFR 129.35(a)(3)(i)). The firm was instructed on the necessity of record retention. Lastly, the bottling room was not adequately separated from other plant operations, specifically lacking a self-closing door to the ozonation room, which poses a contamination risk (violating 21 CFR 129.20(a)). The company agreed to install a self-closing door by September 1, 2011. Other discussions included the need for accurate sample submission documentation and discontinuing the use of correction fluid on official records.