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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pepin Heights Orchard, Inc. 08-Mar-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

March 8, 2006


Refer to MIN 06-21


Dennis H . Courtier
Pepin Heights Orchard, Inc.
R.R. 4, Box 18
Lake City, MN 55041

Dear Mr. Courtier:

On November 16, 2005, an investigator from the Minneapolis District Office collected sample number 350503 of your apple cider. Analysis of this product showed that your product contained 67.2 ppb patulin, with check analysis 88.8 ppb patulin. Patulin is a toxic substance produced by molds that may grow on apples.

Your apple cider was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of Section 402(a)(1) of the Federal Food Drug, and Cosmetic Act (the Act), 21 U.S.C. 342 (a) (1), in that it bears or contains an added poisonous or deleterious substance, patulin, which may render the article of food injurious to health.

In addition, we inspected your firm located at 1753 S. Highway 61, Lake City, Minnesota, on November 15-17, 2005, and found that you have serious deviations from the Juice Hazard Analysis Critical Control Point (HACCP) regulation found in Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). These deviations cause your Apple Cider to be adulterated under Section 402(a)(4) of the Act, 21 U.S .C. 342(a)(4). You can find the Act and the Juice HACCP regulations through links on FDA's home page at www.fda.gov.

The observations of concern to us are as follows:

1. 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 pressing operation does not list the food safety hazard of patulin.

2. You must have a HACCP plan that list the critical limits that must be met, to comply with 21 CFR 120.8(b)(3). However, your firm's HACCP plan for your cider pressing operation lists a critical limit, "Receipt of tanker wash/ sanitization record," at the "Shipping" critical control point that is not adequate to control pathogens. In order to meet this requirement, you must include control measures that will consistently produce, at a minimum, a 5 log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism. This may be assurances that the juice that you produce will be given the required 5-log treatment at another processing location.

3. You must have sanitation control records that document monitoring and corrections to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records of:

  • The condition and cleanliness of food contact surfaces;

  • The prevention of cross-contamination;

  • The maintenance of hand washing, hand sanitizing and toilet facilities;

  • The protection of food, food packaging material, and food contact surfaces from adulteration with contaminants;

  • The proper labeling, storage, and use of toxic compounds;

  • The control of employee health conditions that could result in microbiological contamination of the food, food packaging materials
    and food contact surfaces.

The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations.

Failure to make prompt corrections may result in further enforcement action being initiated by the Food and Drug Administration. This could include seizure of illegal products and/or injunction against your firm.

Please respond to this office in writing within 15 working days of receipt of this letter. Your response should outline the specific things you are doing to correct these deviations and to prevent their recurrence. If you cannot complete all corrections before you respond, please state the reason for the delay and the time within which the corrections will be completed.

Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.



W. Charles Becoat
Minneapolis District