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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sunrise Ocrhards, Inc. 22-Sep-05

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

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


CERTIFIED MAiL
RETURN RECEIPT REQUESTED

WARNING LETTER
(2005-DT-20)

September 22, 2005

Mr. Thomas W. Kercher, President
Sunrise Orchards, Inc.
19498 County Road 38
Goshen, IN 46526-9135

Dear Mr. Kercher:

On February 21 and 23, 2005, an investigator from the Detroit District Office collected two samples, of "Kercher's October Gold...APPLE CIDER 64fl oz"; lot HU4301E. Analysis this product showed that one sample contained [redacted] patulin with check analysis [redacted] ppb patulin, and that the other sample contained [redacted] ppb patulin, with check analysis [redacted] 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 21 U.S.C. 342 (a)(1), Section 402(a)(1) of the Federal Food Drug, and Cosmetic Act (the Act), 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 19498 County Road 38, Goshen, Indiana, on February 15 through 23, 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 "Kercher's October Gold" 100% Pasteurized Apple Cider to be adulterated under section 402(a)(4) of the Act. 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 written 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 apple cider does not list the food safety hazard of patulin.

2. You must have a HACCP plan that lists the critical limits that must be met, to comply with 21 CFR 120.8(b)(3). However, your firm's HACCP plan for apple cider does not list critical limits at the pasteurization critical control point to control pathogens.

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

a. Safety of the water that comes in contact with food or food contact surfaces or that is used in the manufacture of apple cider;
b. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
c. Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves and outer garments, and from raw product to processed product;
d. Maintenance of hand washing, hand sanitizing, and toilets facilities:
e. Production of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
f. Proper labeling, storage,. and use of toxic compounds;
g. Control of employee health conditions that could results in the microbiological contamination of food, food packaging materials and food contact surfaces; and
h. The exclusion of pests from the food plant.

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.

We encourage you to make the necessary improvements as soon as possible. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure or injunction.

If you disagree with our preliminary assessment of the deviations from the juice processing regulation you should explain how your system identifies hazards and implements controls in a manner that the agency should regard as complying with the regulation. We understand that, generally, HACCP systems are uniquely tailored to meet the circumstances of the individual processor and that there may be more than one effective way to control a particular, hazard.

In either case, it is essential that you respond in writing within 15 days from your receipt of this letter. After we received your response, we will work with you to resolve any outstanding issues associated with your HACCP system. If we do not hear from you, or if your response is inadequate, we will assume that our preliminary conclusions are correct and we will schedule a follow-up inspection for the immediate future.

Your reply should be sent to the Food and Drug Administration, Attention: Judith A. Jankowski, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have questions regarding any issue in this letter please contact Compliance Officer Jankowski at 313-393-8125.

Sincerely,

/S/

Joann M. Givens
District Director
Detroit District Office