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Public Health Service |
Minneapolis District Office |
March 29, 2006
WARNING LETTER
Refer to MIN 06-23
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
William F. Meyer
President
Kickapoo Orchard, Inc.
46490 State Highway 171
Gays Mills, WI 54631-9802
Dear Mr. Meyer:
We inspected your juice processing facility located at 46490 State Highway 171, Gays Mills, Wisconsin, on November 18 and 23, 2005. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 and 110). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products 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). Accordingly, your apple cider products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120 .8(b)(1). However, your firm's HACCP plan for your apple cider products does not list the food hazards of pathogens and patulin.
You must have sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records of: condition and cleanliness of food contact surfaces; prevention of cross-contamination; maintenance of hand washing, hand sanitizing and toilet facilities; protection of food products from adulteration; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulation (21 CFR 120) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address listed in the letterhead. If you have questions regarding any issue in this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/S/
W. Charles Becoat
Director
Minneapolis District
Department
of Health and Human Services