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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Quinault Tribal Enterprises 13-Dec-01

DEPARTMENT of Health and Human Services

Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

December 13, 2001
VIA FEDERAL EXPRESS
In reply refer to Warning Letter SEA 02-19
WARNING LETTER

Pearl Bailer, President
Quinault Tribal Enterprises
100 West Quinault Street
Taholah, Washington 98587

Dear Ms. Bailer:

We inspected your firm located at 100 West Quinault Street, Taholah, Washington on September 19-20, 2001, and found that you have serious deviations from the seafood HACCP regulations (21 CFR Part 123). These deviations, some of which were previously brought to your attention, cause your hot smoked vacuum packaged salmon to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov. You may also refer to the Fish & Fisheries Products Hazards & Controls Guide, Third Edition, Chapter 13, Clostridium Botulinum Toxin Formation.

The deviations were as follows:

1. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6(c)(2). Your firm?s HACCP plan for hot smoked vacuum packaged salmon does not list the critical control point of refrigerated storage for controlling the food safety hazard of Clostridium botulinum.

2. You must have a HACCP plan that lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). Your firm?s HACCP plan for hot smoked vacuum packaged salmon does not list the monitoring procedures and frequencies at the identified critical control points to control for the hazard of Clostridium botulinum.

3. You must take an appropriate corrective action when a deviation from a critical limit occurs in your process in order to comply with 21 CFR 12.3.7(a). You do not have a corrective action plan for your hot smoked vacuum packaged salmon. You can follow your own corrective action plan that is appropriate for the particular deviation or follow the procedures according to 21 CFR 123.7(c).

4. You must implement a record keeping system into your HACCP plan, to comply with 21 CFR 123.6(b:). Your firm did not record monitoring observations at any of your identified critical control points listed in your HACCP plan for hot smoked vacuum packaged salmon.

5. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). Your firm did not verify the adequacy of the critical limit of "water phase salt level is [redacted] % for [redacted]" for your hot smoked vacuum packaged salmon at the brining critical control point to control Clostridium botulinum. You are not verifying a minimum of 3.5% water phase salt is achieved in your product to adequately control for this pathogen using this critical limit.

Furthermore, your firm did not verify the adequacy of the critical limit of "cook @ least to 145?F" for this product to control for Clostridium botulinum. For your information, the internal temperature of the fish must be maintained at or above 145? Fahrenheit throughout the fish for at least thirty minutes, in order to control the formation of Clostridium botulinum toxin.

6. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123 .6(b). Your firm does not have a HACCP plan for tuna received frozen, thawed, and canned at your facility to control the food safety hazard of histamines.

7, You must have sanitation monitoring records to document the eight areas of sanitation, to comply with 21 CFR 123.11(C). Your firm has not kept sanitation monitoring records since .April 24, 2001.

Furthermore, your film did not monitor prevention of cross-contamination as evidenced by:

a. Two people passed through the processing area without adequate and smoking.

hair restraint

b. Two loading doors were open throughout the inspection, and numerous flies were seen in the processing area.

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 form 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 (3) 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 documentation 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 in your facility. You are responsible for ensuring that your processing plan operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR 110). You also have the responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please sent your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421, If you have questions regarding any issue in this letter, please contact Lisa Elrand at (425) 483-4913.

Sincerely,
Charles M. Breen
District Director