Inspections, Compliance, Enforcement, and Criminal Investigations
Oregon Ocean Seafoods 30-Aug-06
Department of Health and Human Services
Public Health Service
August 30, 2006
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-43
Norman F. Kujala, President
Oregon Ocean Seafoods
225 SE Galena Avenue
Warrenton, OR 97146
Dear Mr. Kujala:
We inspected your firm located at 225 SE Galena Avenue, Warrenton, Oregon, on July 13-14, 2006. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery 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 canned albacore tuna 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, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR Part 123.3(c) 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 safety hazard." However, your firm's HACCP plan for canned albacore tuna lists a critical limit "no more than 2.5% decomposition in incoming lot" at the receiving critical control point that is not adequate to control Scombrotoxin formation. Please refer to the Hazard Guide, Chapter 7, Histamines for recommendations regarding harvest vessel records, histamine testing, and criteria for testing for decomposition of lots.
2 . You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR CFR 123.6 (b) and (c)(7). However, your firm did not record monitoring observations at the receiving; thawing, processing and precook staging; and raw material storage critical control points (CCP) to control Scombrotoxin formation listed in your HACCP plan for canned albacore tuna. Specifically, you have identified a "receiving record" and "production record" in your HACCP plan, but you have not maintained these records for your monitoring procedures when you have produced this product.
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, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (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.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should 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 your revised HACCP plan and copies of your monitoring records, 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 violations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand, Compliance Officer, at 425-483-4913.
Charles M . Breen