Inspections, Compliance, Enforcement, and Criminal Investigations
Valley Springs Artesian Gold LLC 15-Oct-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 15, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 09-02
Stephen A. Knaus
Valley Springs Artesian Gold LLC
335 S. Thompson Road
Sun Prairie, Wisconsin 53590
Dear Mr. Knaus:
On June 23, 25, 27, and 30, 2008, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your bottled water manufacturing facility, located at N8682 Muskrat Road, Lewiston, Wisconsin. Our findings revealed deviations from the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code, of Federal Regulations, Part 129 (21 CFR 129). By virtue of these
deviations, 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 the regulations through links in FDA's Internet home page at www.fda.gov.
During our inspection, the investigator provided you with a Form FDA 483, which presents his evaluation of your firm's performance regarding various aspects of the bottled water regulation requirements. The following deviations were listed on the Form FDA 483:
1. Failure to retain at the plant current certificates or notifications of approval issued by the government agency or agencies approving the source and supply of product water and operations water, as required by 21 CFR 129.80(h). Specifically, your firm was not able to produce documentation from a government agency or agencies approving the source and supply of product water and operations water.
2. Failure to sample and analyze the product source water obtained from other than a public water system for microbiological contaminants at least once each week, as required by 21 CFR 129.35(a)(3)(i). Specifically, your firm, which obtains water from other than a public water system, does not sample and analyze source water for microbiological contaminants on a weekly basis.
3. Failure to take and analyze samples of product source water at least once every year for chemical contaminants and at least once every four years for radiological contaminants, as required by 21 CFR 129.35(a)(3)(i). Specifically, your firm normally analyzes source water for chemical contaminants every three years, and records indicate that the last sample analysis for radiological contaminants was conducted in 2003.
4. Failure to take and analyze a representative sample of bottled drinking water from a batch or segment of a continuous production run for bacteriological testing at least once a week for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(1). Specifically, your firm does not test bottled drinking water for bacteriological contamination on a weekly basis.
5. Failure to take and analyze, at least annually, a representative sample or segment of a continuous production run of bottled drinking water for chemical, physical, and radiological testing for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(2). Specifically, your firm does not test each type of bottled drinking water on an annual basis for chemical, physical, and radiological contaminants.
6. Failure to separate the bottling room from other plant operations or storage areas, so as to protect against contamination, as required by 21 CFR 129.20(a). Specifically, your bottling room is not separated from storage areas or the loading dock within your firm.
7. Failure to provide adequate ventilation in the bottling room to minimize condensation, as required by 21 CFR 129.20(c). Specifically, condensation droplets were visible on a pipe directly ,over the conveyer of the 1 gallon filling line. Open containers pass under this pipe prior to being filled.
8. Failure to identify each unit package from a batch or segment of a continuous production run of bottled drinking water with a production code which identifies the particular batch or segment of a continuous production run and the day produced, as required by 21 CFR 129.80(e). Specifically, you do not have a lot coding system in place to identify the batch, segment of a continuous production run, or production date of your bottled water products.
9. Not all plant equipment and utensils are suitable for their intended use, as required by 21 CFR 129.40(a)(1). Specifically, (b)(4) multi-purpose grease is used to lubricate components of the 1 gallon bottle filler in locations which could present the potential for contamination of clean containers or the product water passing on the conveyor below. This grease is not a food grade lubricant.
This letter may not list all the deviations at your facility. You are responsible for ensuring your firm operates in compliance with the Act, the bottled drinking water regulations (21 CFR 129), and CGMP regulations (21 CFR 110). You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action, including seizure and/or injunction without further notice.
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 deviations will be corrected.
Please send your reply to the U.S. 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.
W. Charles Becoat