Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Dr., Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
July 18, 2013
RETURN RECEIPT REQUESTED
Ref. KAN 2013-12
Mr. Edward T. Higgs, President
Chesapeake Valley Water Co.
3801 N 2st Street
Ozark, MO 65721
Dear Mr. Higgs:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility on June 18-July 2, 2013. The inspection found significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA's home page www.fda.gov.
Specifically, our inspection of your facility revealed the following CGMP violations:
1. You failed to clean food-contact surfaces and utensils as frequent as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, an FDA investigator observed on 6/24/2013 a grey substance appearing to be grease on the gaskets of your 20 oz. bottle filling equipment. During filling, these gaskets come in contact with the lip of bottles during filling.
2. The plumbing in your facility constitutes a source of contamination to your water supplies and equipment, in violation of 21CFR 110.37(b)(3). An FDA investigator observed waste lines from your water softener, (b)(4) gallon washer/fill station, and (b)(4) still plumbed directly into floor drains with no intervene air gap. This may constitute a route of contamination of waste water into your product and process water supplies.
3. You failed to take necessary precautions to protect against contamination of your food packaging systems with microorganisms and foreign substances as required by 21 CFR 110.10(b). Specifically, an FDA investigator on 6/18/2013 observed your employee operate a forklift and then, without washing his hands first, touch an empty, to-be-filled 20 oz. bottle of Chesapeake Valley Premium Distilled Drinking Water after it had been rinsed and inverted. The investigator also observed the same employee reach into a hopper containing sealing caps used for 5 gallon Chesapeake Valley Premium Drink Water.
This letter may not list all the violations at your facility. You are responsible for ensuring that 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. Failure to 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 of this letter. Your response should include the specific steps you have taken to correct the violations. If 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.
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. A re-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's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-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 related to 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: Gregg P. Oakes, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions, please do not hesitate to call CO Oakes at (913) 495-5113 or send him an email at email@example.com.
John W. Thorsky
Kansas City District Office