| Public Health Service Food and Drug Administration |
| Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, Maryland 21215 Telephone: 410-779-5455 |
Department of Health and Human Services
FEI #: 3006573918
WARNING LETTER
CMS #83729
January 19, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Warren D. Smith, Chief Executive Officer
SweetSommer Water Bottling Company, LLC.
271 Sweet Springs Valley Road
Gap Mills, WV 24941-9713
Ms. Amonda T. Moon, Chief Financial Officer
SweetSommer Water Bottling Company, LLC.
271 Sweet Springs Valley Road
Gap Mills, WV 24941-9713
Dear Mr. Smith and Ms. Moon:
The Food and Drug Administration (FDA) conducted an inspection of your bottled water facility, located at 271 Sweet Springs Valley Road, Gap Mills, West Virginia, on September 15, 16, 18 and 22, 2009. During the inspection, FDA investigators documented serious violations of the Processing and Bottling of Bottled Drinking Water regulations, Title 21, Code of Federal Regulations, Part 129 (21 CFR Part 129). These violations cause the bottled water produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
The violations found during the inspection include:
1. You have failed to sample and analyze 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, you failed to collect and submit weekly water samples for microbiological testing of source water during certain time periods. When you did test samples you frequently tested a composite water sample from the (b)(4) rather than analyzing samples from the individual sources (i.e., from each of your (b)(4) springs).
a. In 2008, your firm only had records for the microbiological testing of source water for 7 weeks, yet other evidence (finished product testing results) collected during the inspection showed that you were producing finished products for at least 18 weeks during 2008. Further, testing was performed on the individual spring source waters only once out of these seven weeks. The remaining six tests were performed on composite samples taken (b)(4)
b. In 2009, your firm had records for the microbiological testing of source water for only one of the 15 weeks of production during the time period of 3/23/09 through 8/31/09.
2. You have failed to establish, based on the results listed below, that your product water supply source (source water) is of safe and sanitary quality, as required by 21 CFR 129.35(a)(1). Further, there was no indication that the results listed below were reviewed by your firm and no documentation was available of any corrective action taken in response to results indicating microbiological contamination.
a. In the only source water test from 2008 where the (b)(4) springs were tested individually, all (b)(4) individual spring samples were found to contain coliforms. (b)(4) of the (b)(4) individual spring samples were also found to contain E. coli, an indicator of fecal contamination.
b. Of the six composite samples from 2008, all six samples were found to contain coliforms. Three of the six samples were also found to contain E. coli, an indicator of fecal contamination.
c. In the one source water test conducted in 2009, all (b)(4) individual spring samples were found to contain coliforms. (b)(4) individual spring sample was positive for E. coli, an indicator of fecal contamination.
3. You have failed to, for bacteriological purposes, take and analyze at least once a week 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)(1).
a. Our review of your 2009 testing records found that you did not collect and submit weekly water samples or lacked weekly analysis for bacteriological testing of finished bottled water products for 11 out of 15 weeks during the time period of 3/23/09 through 8/31/09.
b. You estimated that the company produced bottled water a total of (b)(4) days during (b)(4) week in both January and February 2009. However, your firm does not have any records of bacteriological testing for finished bottled water products from 1/1/2009 to 3/21/2009.
4. You have failed to ensure that your product water supply is from an approved source properly located, protected and operated, as required by 21 CFR 129.35(a)(1). Specifically, the following were observed:
a. Dead mice floating in the waters of Springs (b)(4) and (b)(4)
b. Live salamanders swimming in the water of Spring (b)(4) and near the water in the housing surrounding Spring (b)(4)
c. A live frog inside of the housing surrounding Spring (b)(4).
d. Apparent rodent droppings and rodent nests and nesting materials inside of the housing surrounding Spring (b)(4)
e. An apparent rodent nest and nesting material inside of the housing surrounding Spring (b)(4)
5. You have failed to maintain records, as required by 21 CFR 129.80(a) and 21 CFR 129.80(e), and you have failed to maintain such records for 2 years, as required by 21 CFR 129.80(h). Specifically you failed to maintain the following records:
a. Your firm did not maintain records pertaining to the physical inspections of equipment used for treatment of product water, to include the type and date, conditions found, and the performance and effectiveness of such equipment, as required by 21 CFR 129.80(a). No records were maintained for:
i. Your firm's inspection, maintenance and cleaning of the UV system, filtration system and ozonation system.
ii. Your firm's ozonation system as to performance and effectiveness prior to 3/23/09.
iii. The ozone concentration of the finished bottled water product prior to 3/23/09.
b. Your firm did not maintain production records which documented the kind of product, volume produced, date produced, lot code used, and the distribution of the finished product, as required by 21 CFR 129.80(e) from March 2008 through March 23, 2009.
6. You have failed to ensure that your bottling room is separated from other areas of your manufacturing facility by tight walls, ceilings and self-closing doors to protect against contamination, as required by 21 CFR 129.20(a). Specifically, observed were the following:
a. Your firm's bottling room is separated from your packaging and warehouse operations by a partial wall and plastic sheeting material.
b. Your linear bottled water filler is located approximately 5 feet in front of a door leading to the parking lot.
7. You have failed to properly sample your source water for chemical, physical and radiological quality, as required by 21 CFR 129.35(a)(3)(i). Specifically, you submitted a composite water sample from the reservoir where the source waters are mixed, rather than analyzing the individual spring source waters.
This letter is not intended to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that your bottled water facility operates in compliance with the Act and the bottled water regulations (21 CFR Part 129), and any other applicable laws and regulations administered by FDA. 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to: Anne Aberdeen, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 Baltimore, MD 21215. If you have any questions, please contact Ms. Aberdeen at (410) 779-5134.
Sincerely,
/S/
Evelyn Bonnin
District Director
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