WARNING LETTER
Hood River Juice Company, Inc.
MARCS-CMS 544482 —
April 25, 2018
Recipient:
Hood River Juice Company, Inc.
United States
Issuing Office:
Seattle District Office
United States
Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
April 25, 2018
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply, refer to: WL CMS 544482
David B. Ryan, President
Hood River Juice Company Inc.
550 Riverside Drive
Hood River, Oregon 97031
WARNING LETTER
Dear Mr. Ryan:
The U.S. Food and Drug Administration inspected your juice processing facility, located at 550 Riverside Drive, Hood River, Oregon, from November 27, 2017, through December 6, 2017. 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). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with the requirements of 21 CFR 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 juice 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 on the FDA’s homepage at
www.fda.gov
.
We received your written response, dated December 18, 2017, concerning our investigator’s observations listed on the Form FDA 483 (FDA 483), Inspectional Observations, issued at the conclusion of our inspection on December 6, 2017. We address this response below, in relation to each of the noted violations.
The significant violations include, but are not limited to, the following:
1.  Your HACCP plan must, at a minimum, list all food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). 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 HACCP plan does not identify the food hazard of patulin. We noted that your hazard analysis for pasteurized apple cider (juice), dated September 29, 2017, identified patulin as a hazard likely to occur and indicated that patulin would be controlled through an operational prerequisite program (oPRP) at the Fruit “Inspection and Sorting” step instead of including a critical control point (CCP) or multiple critical control points in your HACCP plan. When an identified food hazard is determined to be reasonably likely to occur, the food hazard must be addressed in a HACCP plan.
Moreover, your Fruit “Inspection and Sorting” oPRP, when added to your HACCP plan, would not be adequate to control the patulin food hazard, as evidenced by our investigator observing damaged fruit on the conveyer line after the inspection and sorting that was conducted on November 27, 2017, and by your firm’s patulin test results indicating levels above 50 parts per billion (ppb). For example, your internal testing found batches JP33289AC, JP33315AC and JP33084AC contained patulin at 187 ppb, 92 ppb and 67 ppb, respectively.
Additionally, your operational limit within your oPRP at the Fruit “Inspection and Sorting” step of “
(b)(4)
% cull fruit per
(b)(4)
apples inspected” would not be adequate as part of your HACCP plan. Even a small percentage of rotten, moldy, and damaged apples may contain high levels of patulin to result in the finished product exceeding FDA’s action level for patulin of 50 ppb. Any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production.
The inspection also found apples were stored outside for extended periods without atmospheric or temperature controls in open, wooden bins. Such storage conditions increase the probability of patulin formation, thus resulting in elevated levels of patulin in the finished product.
According to your response dated December 18, 2017, you intend to perform a new hazard assessment for patulin and reassign your operational prerequisite program (oPRP) for sorting fruit to a critical control point by January 5, 2018. To date, no revised HACCP plan has been provided reflecting that this change has occurred.  FDA recommends you perform a root cause analysis to determine the source of high patulin levels in your apple juice, and implement appropriate CCPs in your HACCP plan accordingly. Prerequisite programs are not sufficient to control a food hazard. Please see FDA’s Juice HACCP Hazards and Control Guidance, Section V.D.1.0, for recommended control strategies for patulin:
http://www.fda.gov/Food/Guidance
Regulation/GuidanceDocumentsRegulatoryInformation/ucm072557.htm
2.  You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with good manufacturing practice regulations, as required by 21 CFR 120.6(b). However, your firm did not monitor for the condition and cleanliness of food contact surfaces and the prevention of cross-contamination from insanitary objects as evidenced by:
a.
Clumps of apple mash on mesh press bags after cleaning, prior to re-use;
b.
Peeling paint with apparent black, mold-like growth on the ceiling above press bags at Presses
(b)(4)
in Plant 1; and
c.
Peeling paint on Press
(b)(4)
above the mesh juice collection conveyor in Plant 1.
According to your response dated December 18, 2017, you intend to revise your pre-operational inspection report to address cleanliness of press bags; however, no documentation has been provided reflecting that this change has occurred. Your response further describes the ceiling in Plant 1 being scrubbed and cleaned to remove peeling paint and mold growth on November 30, 2017, and that the ceiling would be re-sealed by February 23, 2108. Your response describes that press frames in Plant 1 would be repainted by December 20, 2017; however, no documentation has been provided reflecting that this has occurred.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR 120), and all other applicable regulations. You also have a responsibility to use procedures to prevent future violations of the Act and all applicable regulations.
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.
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-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)]. 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.
In addition, we have the following comment:
During our inspection, we noted your practice of blending batches of apple juice that your internal testing found contained patulin above 50 ppb with batches of apple juice with patulin less than 50 ppb, to lower the patulin levels in the finished blends. Please note, as stated in the FDA’s Compliance Policy Guide 555.200, the FDA considers the deliberate mixing of adulterated food with good food renders the finished product adulterated under the Federal Food, Drug, and Cosmetic Act, regardless of the final concentration of contaminant in the finished product.
During our inspection, we noted your practice of diverting batches of apple juice found to contain over 50 ppb patulin to customers that intend to ferment the juice into hard cider or apple cider vinegar. FDA recommends you obtain written assurance from your customers that the diverted batches of apple juice undergo fermentation prior to further distribution.
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 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 written response to the U.S. Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Jessica L. Kocian, Compliance Officer. If you have any questions concerning this letter, you can contact Compliance Officer Jessica Kocian at 425-302-0444.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
cc:
Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301
Content current as of:
05/08/2018