Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ricker-hill-farms-541362-02152018
Timestamp: 2020-07-09 16:10:18
Document Index: 110936720

Matched Legal Cases: ['art 120', 'art 120', 'art 120', 'art 120', '§ 342', '§342', 'art 120', '§ 342', '§ 343', 'art 120', '§ 379', '§ 379']

Ricker Hill Farms - 541362 - 02/15/2018 | FDA
Ricker Hill Farms - 541362 - 02/15/2018
Ricker Hill Farms MARCS-CMS 541362 — February 15, 2018
Mr. Andrew T. Ricker
11 Ricker Hill Rd
Turner, ME 04282-3615
Office of Human and Animal Food Operations East Division 1
CMS # 541362
The U.S. Food & Drug Administration (FDA) inspected your apple cider processing facility, located at 11 Ricker Hill Road, Turner, ME 04282, between August 21st, 2017 and September 9th, 2017. We found that you have serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (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 the requirements of 21 CFR Part 120, or otherwise to operate in accordance with the requirements of Part 120, 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)]. Accordingly, your apple cider is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and guidance, and labeling regulations on FDA’s home page at www.fda.gov.
During the inspection, FDA collected sample 1003993 of “Ricker Hill Orchards Apple Cider” manufactured at your facility on August 31, 2017. Analysis revealed patulin level at 125 parts per billion (ppb). As evidenced by this sample result, your apple cider, represented by sample 1003993, is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(1)].
Patulin is a toxic substance produced by molds that may grow on apples. FDA established an action level for patulin in apple juice of 50 ppb as determined on single strength apple juice or reconstituted single strength apple juice. An action level is a guideline that FDA uses in considering whether the level of contaminant in a food may constitute a health hazard sufficient to warrant regulatory action by FDA against the product. See FDA’s Compliance Policy Guide (CPG Section 510.150) concerning patulin for additional information: https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074427.htm
FDA acknowledges your firm conducted a voluntary recall of Ricker Hill Orchards Apple Cider (half gallon plastic jug, UPC 7461380009) and Northland Apples Sweet Maine Cider (12 ounce plastic bottle, UPC 7461360009).
Additionally, during the inspection of your firm we found the following significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120:
1. Your HACCP plan must, at a minimum, list the critical limits that must be met at each critical control point, to comply with 21 CFR 120.8(b)(3). A “critical limit” is defined in 21 CFR 120.3(e) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.” However, your firm's HACCP plan for "Ricker Hill Orchards Apple Cider" lists a critical limit of, (b)(4) at the "(b)(4)" critical control point. This critical limit is not adequate to control the patulin hazard. FDA recommends that you perform a root cause analysis to determine the source of high patulin levels in your apple juice, implement additional critical control points if necessary, and establish appropriate critical limit(s) in your HACCP plan. Please see FDA's Juice HACCP Hazards and Controls Guidance, Section V.D.1.0, for recommended control strategies for patulin at the following link: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm072557.htm
2. Your firm failed to maintain records documenting the monitoring of critical control points and their critical limits as required by 21 CFR 120.12(a)(4)(i). Specifically, your HACCP plan for “Ricker Hill Orchards Apple Cider” lists “(b)(4)” will be conducted on “(b)(4)” via “(b)(4)” at the “(b)(4)” critical control point and the results will be recorded on a “(b)(4) log.” However, you were unable to provide (b)(4) monitoring records for most of your 2017 production, with the exception of one record dated, August 26, 2017.
3. Since you chose to include corrective actions in your “Ricker Hill Orchards Apple Cider HACCP plan”, your described corrective actions must be (b)(4) to comply with 21 CFR 120.8(b)(5).
a.) Your “Ricker Hill Orchards Apple Cider HACCP plan” at the “(b)(4)” critical control point lists corrective actions of “(b)(4); (b)(4)”. This corrective action does not address correcting the cause of the deviation.
b.) Your “Ricker Hill Orchards Apple Cider HACCP plan” at the “(b)(4)” critical control point lists corrective actions of “(b)(4)”. This corrective action fails to ensure adulterated product does not enter commerce. FDA recommends segregating and holding product for reprocessing.
4. Your firm failed to 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). Specifically:
a.) The cement floor under the filler in the jugging area is pitted and has areas of exposed rocks making it difficult to adequately clean and sanitize. We acknowledge that you plan to address the floor in the jugging area within the next two years. Your response is not adequate. The (b)(4) is being filled and packaged. Insanitary conditions in this area are more likely to cause contamination of your finished product.
b.) The right-hand side of the door frame leading from the cider press area into the apple storage cooler is damaged and missing pieces of wood. You indicated that the door frame would be repaired after the new equipment is installed. We will verify this during our next inspection.
c.) Plastic strip type curtains at the entrance to the apple storage cooler and the entrance to the apple cider room are discolored, ripped and missing pieces. You indicate that the strip type curtains would be replaced within 1 month. We will evaluate the curtains during the next inspection.
Labeling violations noted:
1. Your Apple Cider, Cran-Breeze, McIntosh Blend Carbonated Sweet Cider, Cran-Breeze Lightly carbonated, Maniac Gold, and Mainiac Mac products are adulterated within meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] in that they bear or contain a food additive which is unsafe within the meaning of section 409 of the Act. Specifically, the products are manufactured using (b)(4)). 21 CFR 172.133 does not provide for the safe use of (b)(4) in these products because the juice content in each of these products exceeds 50 percent. Furthermore, the product labels fail to declare the name of the additive “(b)(4)” or the intended use of the additive.
2. Your Apple Cider, Cran-Breeze, McIntosh Blend Carbonated Sweet Cider, Cran-Breeze Lightly carbonated, Maniac Gold, and Mainiac Mac products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Specifically, your products are manufactured using (b)(4); however, you fail to declare this ingredient on your finished product labels.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the 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, seizure and/or injunction.
In addition, we have the following comment:
Your “Ricker Hill Orchards Apple Cider HACCP” plan at the “(b)(4)” critical control point lists verification procedures of “(b)(4)”. During the most recent inspection of your firm, a review of your records revealed that your firm produced approximately (b)(4) lots of (b)(4) Apple Cider from 8/15/16 and 8/31/17 during which time only (b)(4) verification sample was collected and analyzed for patulin. (b)(4) per year is unlikely to be adequate to verify that your firm is controlling the food safety hazard of patulin in your apple cider products.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspectionrelated 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 reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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 documentation in your response such as your HACCP plan, copies of your Sanitation Standard Operating Procedure(s), 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, Attention: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038 or william.rennells@fda.hhs.gov.