Inspections, Compliance, Enforcement, and Criminal Investigations
Sparkle Spring Water Inc. 7/1/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
July 1, 2009
VIA FEDERAL EXPRESS
Charles R. Waterloo, CEO
Sparkle Spring Water Inc.
9064 Hwy 225 North
Chatsworth, Georgia 30705
Dear Mr. Waterloo:
On February 20-27, 2009, representatives of the United States Food and Drug Administration (FDA) inspected your bottled water manufacturing facility located at 9064 Highway 225 North in Chatsworth, Georgia. Their findings revealed violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packing, Or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110), and for Processing and Bottling of Bottled Drinking Water (21 CFR Part 129). By virtue of these violations, the bottled water 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. In addition, the findings revealed violations of the bottled water standard, 21 CFR Part 165. By virtue of these violations, bottled water at your facility is misbranded within the meaning of Section 403(h) of the Act [21 U.S.C. 343(h)], because the product fails to bear a statement that its quality falls below the quality standard for bottled water. We have also reviewed your March 5, 2009 response to the FDA 483. You may find the Act and the CGMP regulations through links in FDA's Internet home page at www.fda.gov.
The violations found during the inspection include the following:
1. You failed to provide source water that is of a safe, sanitary quality, as required by 21 CFR 129.35(a)(1). Our review of 39 of your firm's weekly outside test laboratory reports dated between 10/19/07 and 1/26/09 revealed that 31 of the samples were positive for total coliforms and 15 of those samples were also positive for E. coli, an indicator of fecal contamination. In addition, another outside test laboratory reported your source water sampled on 8/8/07 as positive for total coliforms. The annual testing conducted on the source water on 11/19/08 reported total coliforms as "TNTC [too numerous to count]" and the presence of fecal coliforms. There was no indication that these positive results had been noted by firm officials and no documentation was available of any corrective actions being taken in response to these results (e.g., determine the source of the contamination).
In your response, you stated that you have changed the procedure for taking a sample. We agree that your firm's collection method procedure should be adjusted to an aseptic sampling technique. However, your response does not address the lack of documentation
of any corrective actions taken when the spring source water tests positive. You have not determined the source of the spring's contamination in order to prevent future contamination and ensure the water supply is of a safe, sanitary quality.
2. Both the 2007 and 2008 annual finished product testing reports indicate that your product failed to meet the quality standard for bromate. The allowable level for bromate is 0.01 mg/L [21 CFR 165.110(b)(4)(1)(H)]. However, the 8/7/07 analysis indicated a bromate
level of 0.017 mg/L and the 11/18/08 analysis indicated a bromate level of 0.019 mg/L. You failed to take corrective actions to address the elevated bromate levels. You failed to include a statement of substandard quality on the product's label as required by 21 CFR 165.110(c)(3).
In your response, you stated that you had adjusted the ozone levels. However, your firm does not have a method that can determine the specific level of ozonation needed to produce water that complies with the bottled water quality standard. In those instances where your finished product testing reveals excessive bromate levels, you have not provided any documentation of corrective action relating to the adjustment of the ozonation system or other actions taken pertaining to finished products produced during these time periods. We note that no apparent action has been taken by your firm to address these issues other than to submit another sample for retesting in 2008.
3. You have failed to take and analyze for chemical, physical and radiological purposes at least annually a representative sample from a batch of each type of bottled drinking water produced during a day's production run as required by 21 CFR 129.80(g)(2). Specifically, in 2008, no testing was performed of the purified water produced via reverse osmosis.
We acknowledge that your response states that you are no longer producing purified water via reverse osmosis.
4. You failed to maintain records pertaining to the physical inspection of equipment used for treatment of product water, to include the type and date, conditions found, and performance and effectiveness of equipment, as required by 21 CFR 129.80(a). No records were maintained of your firm's ozone system as to performance and effectiveness. No records were maintained of the inspection, maintenance and cleaning of the UV systems, filtration systems, ozonation system, distillation system or reverse osmosis system.
With your response, you provided invoices showing the purchase of filters and UV bulb replacements. However, the invoices do not provide assurance that the filters or UV light bulbs were appropriately installed to ensure their effectiveness. This will be verified during our next inspection.
5. You have failed to inspect your mechanical washers to ensure adequate performance, and to maintain records of physical maintenance, inspections and conditions found, and performance of the washers, as required by 21 CFR 129.80(b)(1). Your Quality Manager indicated that no inspection of the mechanical washers used for the finished product containers was being conducted. The only monitoring records that could be located were dated 1/19/09 - 2/3/09.
Your response stated that you put into place a procedure to inspect the mechanical washers on a regular basis, however, you did not include any documentation of this procedure being performed.
6. You have failed to sample and test cleaning and sanitizing solutions utilized to ensure adequate performance in the cleaning and sanitizing operations, and to maintain records of these tests, as required by 21 CFR 129.80(c). Your Quality Manager indicated that no
sampling or testing of these solutions was conducted. Your employees were not following established procedure for preparing these solutions. There were no methods or equipment available which could measure the strength of these solutions.
Your response states that you will put into place a procedure to sample and test sanitizing solutions; however, you did not describe the intended procedures.
7. You have failed to treat source water in a manner so as to be effective in accomplishing its intended purpose, as required by 21 CFR 129.80(a). Specifically, you informed the FDA inspector that in response to the positive sample found by the Georgia Department
of Agriculture you "shocked" the source water with chlorine and tested it for residual chlorine on February 20-21, 2009. There are no records available of how that was performed or that this process was safe and effective.
8. As described above, you treated your source water with a chlorine-based disinfectant when you "shocked" the source water with chlorine. However, you failed to test the chlorine-treated source water for the disinfection byproducts listed in 21 CFR165.110(b)(4)(iii)(H) likely to result from such treatment, and to maintain records of these tests, as required by 21 CFR 129.35(a)(4)(iii).
9. You have failed to take product water samples after processing and prior to bottling as required by 21 CFR 129.80(a). According to your Quality Manager, the samples were being obtained only after bottling.
Your response states that your employees were instructed by the state inspector in the proper method to capture a finished product sample. However, your response did not address the specific method you intend to use to capture the finished product sample.
10. Your employee failed to wash their hands thoroughly in an adequate hand washing facility after each absence from the work station, as required by 21 CFR 110.10(b)(3). Although your procedures require that your employees wash and sanitize their hands each time they enter the clean room, FDA observed one of your employees not washing his hands before entering the processing room.
Your response states that employees had been retrained. However, your response does not document how the employees were trained.
11. You have failed to ensure that all plant equipment and utensils are suitable for their intended use, as required by 21 CFR 129.40(a)(1). Our investigators observed five pipes leading from the spring house to the outside that did not contain back-flow prevention devices. In addition, four of those pipes did not contain a screening device to prevent the entry of extraneous materials or pests into your source water.
Your response provided a diagram from a consultant's report showing where backflow preventers are required. However, the diagram does not address the remaining pipes that drain water from the spring to the outside of the spring house.
The above-identified violations are not intended to be an all-inclusive list. The investigators issued a list of their Inspectional Observations (FDA 483) to you at the conclusion of their inspection. Although not listed on the FDA 483, the investigators also discussed their concern over several of the laboratory collection and testing methods not being performed correctly or according to the test kit manufacturers' recommendations. You are responsible for ensuring your firm operates in compliance with the Act, the bottled water standard regulations, and CGMP regulations. 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 with fifteen (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.
In addition, we have the following overall comments regarding your response:
• In your response, you stated that the bottling equipment is a self-contained unit. However, this equipment was observed with several side panel doors removed and stored directly on the floor when the equipment was not in operation.
• During the inspection, you stated that the candidates for the quality assurance position had extensive textile manufacturing experience. Due to the critical nature of the position, it is important that this person receive appropriate food manufacturing training.
Your reply should be sent to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Barbara A. Wood, Acting Director