Inspections, Compliance, Enforcement, and Criminal Investigations
Paradise Farm Corporation 22-Dec-05
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
RETURN RECIEPT REQUESTED
December 22, 2005
Harry S. Patten
Paradise Farm Corporation dba Green River Farms
665 Simons Road
Williamstown, MA 01267
Dear Mr. Patten:
We inspected your juice processing facility, Paradise Farm Corporation, located at 2480 Green River Road, Williamstown, MA on November 15, 2005 and found that you have serious deviations from the Juice HACCP regulations (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part 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). These deviations cause your apple cider to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the juice HACCP regulations through links in FDA's home page at www. fda.gov.
The deviations were as follows:
1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for your apple cider to control the food safety hazard 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 the apple cider that you process.
2. You must maintain 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 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; proper labeling, storage, and use of toxic compounds; control of employee health conditions ; and, exclusion of pests.
We may take further action if you do not promptly correct these violations . For instance, we may take further action to seize your product and /or enjoin your firm from operating.
Please 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 deviations. You may wish to include in your response documentation such as a copy of your HACCP plan for apple cider, 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 the Current Good Manufacturing Practice regulations for food (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.
You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the address noted above. If you have any questions concerning this matter, please contact Ms. Archdeacon at (781) 596-7707.
Gail T. Costello
New England District Office