Inspections, Compliance, Enforcement, and Criminal Investigations
Dakota Pure Water, Inc. 8/29/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
August 29, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 49
Kevin J. Wittmayer
Dakota Pure Water, Inc.
3431 Fourth Avenue SW, Suite B
Fargo, North Dakota 58103-2227
Dear Mr. Wittmayer:
On June 3 and 6, 2011, a Food and Drug Administration (FDA) investigator conducted an inspection of your bottled water manufacturing facility located at 3431 Fourth Avenue SW, Suite B, Fargo, North Dakota. Our findings revealed violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129, and the Current Good Manufacturing Practice regulation for foods, 21 CFR Part 110.
By virtue of these violations, the product processed at your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s Internet home page at www.fda.gov.
The FDA investigator provided you with a form FDA 483, which presents the investigator’s observations. The following violations were observed, some of which were also noted during FDA’s previous inspection of your facility in April 2009:
1. You have failed to take and analyze product samples for bacteriological purposes at least once a week from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day’s production, as required by 21 CFR 129.80(g)(1). This requirement applies to all finished bottled water products, regardless of source. Specifically, since the conclusion of your last FDA inspection on April 30, 2009, you have not submitted weekly samples for bacteriological analysis. Records show that you submitted water samples to (b)(4) only on the following dates, although water is typically bottled each week of the year:
• 2009: May 7, July 23, and October 15
• 2010: March 9, March 17, April 6, June 2, July 27, September 29, November 9, November 18, and December 27
• 2011: January 3, February 7, March 7, March 16, March 30, and April 19
2. You have failed to take and analyze at least annually for chemical, physical, and radiological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day’s production, as required by 21 CFR 129.80(g)(2). This requirement applies to all finished bottled water products, regardless of source. Specifically, you have not submitted any samples for chemical, physical, or radiological analysis since your last FDA inspection on April 30, 2009. Failure to conduct annual chemical, physical, and radiological testing of bottled water products was also noted during the previous inspection.
3. You have failed to store and hold toxic chemicals in a manner that protects against contamination of food, food-contact substances, or food-packaging materials, as required by 21 CFR 110.35(b)(2). Specifically, the FDA investigator observed open containers of various household chemicals stored in the production area near the water bottling area and water coolers.
4. You have failed to provide running water at a suitable temperature in your hand-washing facilities, as required by 21 CFR 110.37(e). Specifically, your employees informed the FDA inspector that the sink used for hand washing lacked hot water, and this was verified by the FDA investigator. Water was cool to the touch and remained cool to the touch after the faucet ran for four minutes.
This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations, including the bottled water regulations (21 CFR Part 129), and the Current Good Manufacturing Practices regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
In addition to the violations discussed above, we have the following comment. You have failed to sample and inspect containers and closures to ascertain that they are free from contamination, as specified in 21 CFR 129.80(f).
We received your letter dated June 28, 2011, which responded to the FDA 483. Although your response indicates that corrections have been made, the response is inadequate because it does not include any documentation or records to show that you have made the necessary corrections.
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.
Please send your reply to the Food and Drug Administration, Attention: Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have questions regarding the issues in this letter, please contact Mr. Philips at (612) 758-7133.
Gerald J. Berg