Inspections, Compliance, Enforcement, and Criminal Investigations
Norquest Seafoods, Inc. 30-Aug-01
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
August 30 ,2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-80
Terry Gardiner, President
Norquest Seafoods, Inc.
4225 23rd Avenue West
Seattle, Washington 98199
Dear Mr. Gardiner:
On April 11 and 12,2001, Investigator Mark E. Moen inspected your firm located at 1705 Tongass Avenue, Ketchikan, Alaska, and found that you have serious deviations from the Seafood HACCP regulations [21 Code of Federal Regulations (CFR) 123]. These deviations, some of which were previously brought to your attention, cause whole cooked Dungeness crab and frozen cooked Dungeness crab sections processed by your firm to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s home page at www.fda.gov. The deviations were as follows:
- You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur in order to comply with 21 CFR 123.6(b). Your firm does not have a HACCP plan for whole cooked Dungeness crab to control the food safety hazard of pathogen survival through cooking.
- You must have a HACCP plan that lists monitoring procedures for each critical control point in order to comply with 21 CFR 123.6(c)(4). However, your firm?s HACCP plan for frozen cooked Dungeness crab lists a monitoring frequency at the cook critical control point that is not adequate to control pathogen survival through the cook. Continuous monitoring of the water temperature is needed to detect temperature fluctuations during the cook.
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.
In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
Please respond in writing within three weeks 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 documents 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.
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 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.
Please send your reply to the Food and Drug Administration, Attention: Thomas S. Piekarski, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter please contact him at 425-483-4975.
Charles M. Breen