Public Health Service Food and Drug Administration
Kansas City District
8050 Marshall Drive
February 26, 2015
Mr. Elliott Henry, Owner
Unlimited Water Processing, Inc.
6891 Hazelwood Ave.
Saint Louis, MO 63134
Dear Mr. Henry:
On November 4 thru 11, 2014, Food and Drug Administration (FDA) investigators conducted an inspection of your bottled water manufacturing facility located at 6891 Hazelwood Ave, Saint Louis, MO 63134. Our findings revealed serious deviations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129, and the Current Good Manufacturing Practice regulation for foods, 21 CFR Part 110. These deviations render the bottle 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 the product has been prepared, packed, or held under insanitary conditions where by it may have become contaminated with filth, or whereby it 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.
We acknowledge receipt of your written response, dated December 3, 2014, to the Form FDA 483, lnspectional Observations, issued to your firm on November 14, 2014. We remain concerned about the significant violations, as well as the corrective actions you described in your response, as follows:
You failed to conduct follow-up testing to determine if any of your 3 manufactured 5 gallon returnable bottle water production lots, which tested positive for total coliform, were positive for E.coli, as required by 21 CFR 129.80(g)(1). This requirement to test forE.coli applies to all finished product bottled water products when any coliform organisms are detected. Specifically you sent, on or about July 10, 2014, 5 gallon returnable bottle water from lot numbers 6015414, 6016014, and 6016214 to your contract testing laboratory to be analyzed for total coliforms. These lots testedpositive for total coliforms respectively; (b)(4)CFU (Colony Forming Unit)/100mL, (b)(4)CFU/100mL, and(b)(4)CFU/100mL. However, you failed to conduct follow-up testing to analyze for E.coli in those lots of product. We acknowledge your December 3, 2014, response to the FDA-483 that includes a signed letter from your service laboratory in which you requested notification of any positive test results so that you can take action to not ship out affected bottled water product; however, you failed to address the issue of shippingout coliform positive bottles that exceeded coliform limits per 21 CFR 165.110(b)(2)(i)(A). You also failed to address the issue of follow-up testing for E.coli and disposition of any affected lots. Please note that re-testing affected lots of product to determine compliance is not an appropriate corrective action when E.coli is found during follow-up testing.
You failed to analyze weekly production samples, for each type of bottled drinking water produced, for total coliform, as required by 21 CFR129.80(g)(1). Your management stated weekly production occurred during 2014. Your analysis records indicate that from January 1, 2014 to September 27, 2014, you did not conduct weekly production samples for 17 of those weeks.
You failed to maintain records at the plant pertaining to physical inspection of the equipment used for treatment of product water, including the type and date of physical inspections of equipment, conditions found, and performance and effectiveness of equipment, as required by 21 CFR129.80(a). Specifically, you did not maintain records of the treatment processes and equipment (e.g. a record of maintenance of the(b)(4) equipment,record of filter changes, or log of pH calibrationat the frequency recommended by the pH equipment manufacturer, etc.). Your December 3, 2014, response included log sheet templates for a variety of parameters; however, equipment maintenance parameters were not addressed and there was no evidence of actual implementation of your record-keeping.
You failed to take bacteriological swabs or rinse counts at least every three months from at least four containers and closures that your firm has selected just prior to filling and sealing, as required by 21 CFR 129.80(t). At the time of the inspection, your most recent swab tests collected were from March 29, 2013, which exceeds the every three month frequency requirement. Your December 5, 2014, response states that you conducted swabtesting on December 3, 2014; however you failed to address collecting future bacteriological swab tests to meet the frequency requirement of the regulation.
You failed to assure the use of equipment and utensils during processing would not adulterate the food with lubricant and contaminants, as required by 21 CFR 110.40(a). Specifically, you have a transfer motor located on your small bottle line cap conveyor which was leaking oil, which may have entered the conveyor or cap overflow return lines. Your December 5, 2014, response states that you have washedthe gear box and thoroughly cleaned the cap hopper, and you also plan to rebuild the unit to include seals and use food grade oil. We will verify the outcome of these proposed corrective actions during our next inspection.
In addition, we acknowledge that your December 3, 2014, response includes a proposed drawing of site plans to construct a (b)(4). Based on your proposed drawing,(b)(4). Your proposed plan appears to address the requirement that "the bottling room shall be separated from other plant operations or storage areas by tight walls, ceilings, and self-closing doors to protect against contamination". However, you should ensure that the size of your conveyor openings do not exceed the size required to permit passage of containers, as required by 21 CFR 129.20(a). We will verify this during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failureto promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products, injunction and/or prosecution.
We request that you notify this office in writing, within fifteen (15) working days of receipt ofthis letter, of any additional steps you have taken to correct the noted deviations and to prevent their recurrence. lf you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed. Please include copies of any available documentation that corrections have been made.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. Are-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA'sarranging, conducting, and evaluating the results of there inspection and assessing and collecting the re-inspection fees [21 U.S.C.§ 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially relatedt o a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be directed to: Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 210 Walnut St., Suite 369, Des Moines, lA 50309. If you have any questions, pleasedo not hesitate to call CO Hoopes at (515) 244-0480 ext. 1002 or send him an email at firstname.lastname@example.org.