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WARNING LETTER
NWE-03-06W
VIA FEDERAL EXPRESS
December 21, 2005
Thomas G. Clark
President
Clarkdale Fruit Farms Inc.
303 Upper Road
Deerfield, MA 01342
Dear Mr. Clark:
We inspected your juice processing facility, located at 303 Upper Road, Deerfield, MA on October 19, 2005, and found that you have serious deviations, from the FDA's juice processing regulation 21 CFR Part 120) . These deviations cause your [redacted] cider to be in violation of 21 CFR Part 120, promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act). You can find the PHS Act and the juice HACCP regulation through links in FDA's home page at www.fda.gov.
The observations of concern to us are as follows:
You must have a written HACCP plan to control any food safe hazards that are reasonably likely to occur, to comply with 21 120.8(a). However, your firm does not have a HACCP plan for your [redacted] cider to control the food safety hazards of Pathogens. Furthermore, your firm does not have a written hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards for your [redacted] cider.
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 for the safety of water; the condition and cleanliness of food contact surfaces; the prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, and from raw product to processed product; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants; control of employee health conditions; and, exclusion of pests.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the PHS Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Public Health Service Act and all applicable regulations.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, an injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us i evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and tate when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention : Anthony P. Costello, Compliance Officer, 4th Floor, 1 Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issue in this letter, please contact Mr. Costello at 781596-7716.
Sincerely,
/s/
District Director
New England District Office
Department
of Health and Human Services