Paul L. Rasch
- Fox Ridge Farm, Inc. DBA Wilsons Orchard
1998 Poplar Ave NE
Solon, IA 52333
- Issuing Office:
- Kansas City District Office
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Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
January 20, 2017
CMS # 510892
Paul L. Rasch, President/Co-Owner
Fox Ridge Farm, Inc. DBA Wilson’s Orchard
1998 Poplar Ave NE
Solon, IA 52333-9661
Dear Mr. Rasch:
We inspected your juice processing facility located at 1998 Poplar Ave NE, Solon, IA on October 18-19, 2016. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). At the conclusion of the inspection, a Form FDA-483, Inspectional Observations, was issued which listed the deviations found during the inspection of your firm. To this date, we have not received any correspondence from your firm in response to the Form FDA-483 indicating that you have corrected the problems.
In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP system that complies with 21 CFR Part 120, 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 [21 U.S.C. § 342 (a) (4)]. Accordingly, your apple cider products are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your juice products, can
be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/default.htm
We found the following significant deviations:
1. You must have and implement a written HACCP plan that, at a minimum, lists all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your firm does not have a HACCP plan for your apple cider product to control the food hazards of pathogens, patulin, and metal fragments. During the inspection, you provided our investigator with a document titled “Hazard analysis and CCP” which identifies the food hazards of pathogens (E. coli O157:H7 and Cryptosporidium parvum), patulin, and metal fragment as significant food hazards requiring control in a HACCP plan. However, your firm had not yet drafted a HACCP plan during our inspection.
Further, your hazard analysis document indicates that you will control the patulin hazard through the implementation of your SOP. Prerequisite programs are not sufficient to control a food hazard.
2. 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 following areas of sanitation: monitoring the safety of the water that comes into contact with food or food contact surfaces; the prevention of cross-contamination from insanitary objects; 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; and the exclusion of pests from the food plant. During our inspection, you provided a copy of your one page “Cleaning Form” which only lists the concentration, temperature, and duration of the cleaning chemicals used in your facility. You also told our investigator that you use a pest control company to monitor rodent activity; however, you do not keep any records to document pest control monitoring or corrections.
3. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration with contaminants; the proper labeling, storage, and use of toxic compounds; and the exclusion of pests from the food plant with sufficient frequency, as evidenced by our investigator observing the following:
• The cider press line used to make sweet cider has rusty and corroding surface areas, which come in contact with the apples that go into the product.
• There are no directions for proper use of your (b)(4)” caustic cleaner being used on your apple cider processing equipment.
• Two dock doors and a door next to your cider press line were left open during production. We observed flying insects next to the cider press line and apparent mosquitos too numerous to count in the break room and packaging storage area. Your contract pest service does not include insect control. In the break room and the production area near the pasteurizer, (b)(4) traps with sticky tapes were used to control insects and the sticky tapes were seen covered with dead insects during our inspection.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Public Health Service (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 PHS Act and all applicable regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to asses and collect fees to cover FDA’s costs for certain activities, including re-inspection–related costs. A re-inspection is one or more inspection conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance had been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)].
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 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.
Please send your reply to the Food and Drug Administration Kansas City District Office, Attention: Victoria A. Wagoner, Compliance Officer, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have questions regarding any issues cited in this letter, please contact Ms. Wagoner at 913-495-5150 or at email@example.com.
Cheryl A. Bigham
Kansas City District