Inspections, Compliance, Enforcement, and Criminal Investigations

Sweet Springs Valley Water Co., Inc. 3/7/17

 

  

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Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215
Telephone: 410-779-5455
Fax: 410-779-5705

 

WARNING LETTER
CMS#513227
 
March 7, 2017
 
Ms. Mabel Cox, Manager
Sweet Springs Valley Water Company
1598 Rowan Road
Gap Mills, WV 24941
 
Dear Ms. Cox:
 
The U.S. Food and Drug Administration (FDA) inspected your bottled water manufacturing facility located at 1598 Rowan Road, Gap Mills, WV on August 2-4, 8 & 17, 2016. Our inspection revealed significant violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129. These violations render the bottled water products processed at your facility 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 they have been prepared, packed, or held under insanitary conditions where by they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s Internet homepage at www.fda.gov.
 
On August 22, 2016, we received your response letter regarding our observations noted on the form FDA-483 which was issued at the conclusion of the inspection. We have addressed the response below, in relation to each of the noted deviations.
 
Your significant deviations were as follows: 
  • You are required to be in compliance with 21 CFR 129.35(a)(3) to take appropriate measures to rectify or otherwise eliminate the cause of Escherichia coli (E. coli) contamination of source water in a manner sufficient to prevent its reoccurrence and specifically required to comply with 21 CFR 129.35(a)(3)(i) that states “A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24hr period from the same site that originally tested positive for E. coli are tested and found to be E. coli negative.” However, review of several analytical results for source water from your (b)(4), (b)(6) and (b)(4), (b)(6) in 2016 revealed that they were positive for E. coli. You did not provide documentation to show that additional samples were collected, analyzed and negative for E. coli prior to resuming use of the source water for bottling. Your response stated that this occurred due to an oversight, however you did not provide any information regarding how you intend to achieve compliance with this part of the regulation.
  • You are required to be in compliance with 21 CFR 129.35(a)(3)(i) to maintain “records describing corrective measures taken in response to a finding of E. coli are to be maintained on file at the plant.” We found that you did not have any records describing corrective measures taken in response to a finding of E. coli present in the source water.
  • You are required to be in compliance with 21 CFR 129.80(g)(1) to conduct follow-up testing to determine whether any of the coliform organisms detected in finished bottled water are E. coli. On July 9, 2015, your testing records showed that an undetermined amount of coliforms were found in the finished bottled water product. However, you did not conduct any follow-up testing to determine if any of these organisms are E. coli. Your response stated that you would recheck all samples if the results are high. Your response is not adequate in that it does not convey that you will perform follow-up E. coli testing when coliform organisms are detected in the finished bottled water.
  • You are required to be in compliance with 21 CFR 129.80(f) to ensure that no more than one of four containers and closures sampled may “exceed more than one bacteria per milliliter of capacity or one colony per square centimeter of surface area.” Analyses of containers and closures identified that three out of four closures collected on March 3, 2016, four out of four 5-gallon containers collected on June 8, 2015, and two out of four 3-gallon containers collected on June 8, 2015, had more than one bacteria per milliliter. Furthermore, in compliance with 21 CFR 129.80(f) you are also required to ensure that all samples are free of coliform organisms. On multiples dates in 2015 and 2016, you did not conduct any analysis to test for coliforms when there were positive bacteria counts for containers and closures. You responded that you did not understand the coliform testing and that the inspector has provided you with a guide for this test, however, you did not provide any information regarding how you intend to achieve compliance.
  • You are required to be in compliance with 21 CFR 165.110(b)(4)(i)(A) to ensure that your bottled water meets the maximum allowable level of 0.001 mg/L for phenols under the quality standard for chemical contaminants in bottled water. You collected finished bottled water product samples and found phenols at (b)(4), (b)(6) on March 9, 2016. Therefore, your finished bottled water product did not meet the maximum allowable level for phenols as required by 21 CFR 165.110(b)(4)(i)(A). You responded that you have collected more water for analysis, however you did not provide the data. 
In addition, FDA has the following concerns:
    • On March 5, 2015, a sample of source water collected from the (b)(4), (b)(6) tested positive for E. coli. You conducted subsequent testing on March 11, 2015, and one out of the five samples tested positive for E. coli. You appeared to have continued using the source water from the (b)(4), (b)(6) despite the positive E. coli finding. Your response indicated that there was a charting error and you had switched from one source to another. However, you have not provided any evidence that it was a charting error.
    • During the inspection, FDA observed that bottles were in contact with ozonated water for 53 seconds on August 17, 2016 and the ozone concentration was recorded by employees at levels between 0.3-0.8 ppm. Your response states that you have adjusted the machine to keep the ozone concentration at 0.5 ppm. However, your response did not acknowledge that contact time also needs to be corrected. In addition, FDA has not been provided evidence showing that 0.5 ppm for 1 minute is equivalent to the 0.1 ppm for 5 minutes requirement described in 21 CFR 129.80(d)(4).
    • During the inspection, FDA observed the spray of product water on the ceiling, sides and other interior surfaces of the firm’s machinery and the water subsequently dripped inside the finished product. We also observed areas of rust and hard water deposits. Your response indicated that you have adjusted the filler on the machine. You did not provide any information on how you plan to prevent product contamination from rust and hard water deposits inside the filler.
The above violations are not intended to be an all-inclusive list of violations in your plant. It is your responsibility to ensure your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by the FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps toward long term corrective actions.
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
If you have any questions regarding this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at (410) 779-5437 or rochelle.young@fda.hhs.gov.
 
Sincerely,
/S/ 
Evelyn Bonnin
District Director

Page Last Updated: 05/18/2017
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