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NWE-12-06W
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 21, 2006
David A. Knight
President
Smiling Hill Farm Inc.
781 County Road
Westbrook, ME 04092
Dear Mr. Knight:
We inspected your firm, located at 781 County Road, Westbrook, ME on January 17, 19, and 24, 2006 and found that you have serious deviations from the Juice HACCP regulations (21 CFR Part 120). These deviations, some of which were previously brought to your attention, cause your product, pasteurized orange juice to be in violation of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the Juice HACCP regulation through links in FDA's home page at www.fda.gov.
The deviations were as follows:
You must have a HACCP plan that lists the monitoring procedures for each critical control point to comply with 21 CFR § 120.8(b)(4). However, your firm's HACCP plan for your pasteurized orange juice lists a monitoring frequency at the pasteurization critical control point that is not adequate to control pathogens. Specifically, quarterly checks of the charts recording pasteurization temperatures and times will not ensure compliance with the critical limit and will not permit appropriate corrective action if a deviation from the critical limit occurs.
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 controls of:
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;
Maintenance of hand washing, hand sanitizing and toilet facilities;
Prevention 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;
Proper labeling, storage and use of toxic compounds;
Control of employee health conditions that could result in the microbial contamination of food, food packaging materials, and food contact surfaces; and
The exclusion of pests from the food plant.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331 (dd). Our records indicate that, to date, your facility has not been registered with FDA.
We request that the owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g ., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681I
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
We may take further action if you do not promptly correct these violations. For instance, we make take further action to seize your product and/or enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from the 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, sanitation control monitoring records or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Anthony P. Costello, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, MA 02180. If you have any questions regarding any issue in this letter, please contact Mr. Costello at 781 596-7716.
Sincerely,
/S/
Gail T. Costello
District Director
New England District
Department
of Health and Human Services