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U.S. Department of Health and Human Services

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Enforcement Actions

Everett Fisheries, Inc. 18-Aug-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7118
FAX: (612) 334-4142




August 18, 2006

WARNING LETTER
Refer to MIN-06-34

CERTEFIED MAIL
RETURN RECEIPT REQUESTED

Christopher Johnson
President
Everett Fisheries, Inc.
9250 Sunnyside Lane, P.O. Box 85
Port Wing, WI 54865-4713

Dear Mr. Johnson:

We inspected your seafood processing facility, located at 9250 Sunnyside Lane, Port Wing, Wisconsin, on June 28-30, 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 and 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 smoked fish 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 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 are as follows:

1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point to comply with 21 CFR 123.6(c)(4). Specifically, the monitoring procedures and frequencies listed in your "HACCP Flowchart Worksheet" (i.e., HACCP plan) are inadequate. Specifically:

  • The monitoring procedures and frequencies listed in your HACCP plan at the "brining" and "overnight salmon drying" critical control points (CCP) are not adequate to control pathogen growth and toxin formation specifically Staphylococcus aureus toxin formation. Your plan lists that you will record brining temperatures in a daily log and that you will only monitor overnight drying temperatures at the start and end of the night. FDA currently recommends that you implement some method of assuring that safe brining and drying temperatures are maintained throughout the duration of these entire processes. For example, we recommend the use of equipment that is capable of continuously monitoring and recording the temperatures, with a review of these records prior to proceeding to the next CCP to ensure that temperatures are adequately maintained for the entire duration of the processing step.

  • In addition, your HACCP plan does not list a monitoring frequency at the "smoking" critical control point. Moreover, the monitoring procedure lists that "loin muscle of the fish" must be maintained at 145°F for 30 minutes, while temperature of the ovens is listed as what is to be monitored.

  • Additionally, your monitoring frequency at the finished product storage critical control point is inadequate as a control for pathogen growth and toxin formation. Your listed monitoring frequency is to download the digital temperature logger every two weeks. FDA currently recommends a daily visual review of automated recorded temperature data log information to ensure that your listed critical limits are not exceeded and that product exposed to unsafe conditions does not enter commerce. Your current frequency of monitoring does not appear to provide an equivalent degree of safety.

2. You must maintain sanitation control records that, at minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 123.11(c). However your firm did not maintain sanitation monitoring records that document monitoring and corrections of sanitation deficiencies for safety of water (i.e., your well water) that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests.

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.

In addition, the Investigator observed brown sugar being spread on each salmon fillet before the fish was placed in the smoker for cooking. We noted that brown sugar is not listed as an ingredient on the label collected.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

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 seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Judy E. Heisick, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Heisick at (612) 758-7118.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District