- Sweet Springs Valley Water Co., Inc.
- Issuing Office:
- Baltimore District Office
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215
- 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.
- 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.