Inspections, Compliance, Enforcement, and Criminal Investigations
L. Neil Jones Food Company dba Northwest Packing Company 15-Apr-08
Department of Health and Human Services
Public Health Service
April 15, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-13
J. Matthew Jones, Chief Operating Officer
L. Neil Jones Food Company dba Northwest Packing Company
P.O. Box 30
Vancouver, Washington 98666
Dear Mr. Jones:
We inspected your juice processing facility, located at 1701 West 16th Street; Vancouver, Washington, on January 10, 11, and 16; 2008. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 120, and the Good Manufacturing Practice (GMP) regulations for foods, Title 21; Code of Federal Regulations, Part 110 (21 CFR Parts 120 and 110). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise 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 juice concentrate 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 can find the Act and the juice HACCP regulation and GMP regulation through links in FDA's homepage at http://www.fda.gov.
The significant violation was as follows:
You must have a HACCP plan for each type of juice product that you process that lists the food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). Patulin is a toxic substance produced by molds that may grow on apples, and review of records pertaining to a number of lots of your finished apple juice concentrate found that patulin existed in the product at levels that may render it injurious to health (i.e., above 50 parts per billion). However, your firm's HACCP plan for juice concentrate does not list patulin as a food hazard that is reasonably likely to occur in your apple juice concentrate. The presence of patulin at these levels in your finished apple juice concentrate indicates that patulin is a food hazard that is reasonably likely to occur in this product. Therefore, this hazard must,be addressed in your HACCP plan for this product.
We note that your practice of addressing the hazardous levels of patulin in specific lots
of your apple juice concentrate by blending those lots with higher levels of patulin, with
lots that contain acceptable levels of patulin, is not an acceptable means of addressing
the hazard of patulin and may result in the adulteration of the blended product. You can
find FDA's policy regarding mixing adulterated food with nonadulterated "good" food in
FDA's Compliance Policy Guide, Section 555.200, at the following, internet address:
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 steps you are taking to correct the noted violations. You may wish to include in your response documentation such as amended juice HACCP plans, revised forms, or other useful information. that would assist us in evaluating your corrections. If you are unable to complete all of the 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 violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulations (21 CFR 120), and Current Good Manufacturing Practice regulations (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the U.S. Federal Food, Drug and Cosmetic Act and all applicable regulations.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M, Breen
Copy of FDA 483
cc: WSDA, with disclosure statement