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Western United Fish Company, Inc. Response Letter

 

Western United
Fish Co., Inc.

Your Direct Source

5/29/08

VIA CERTIFIED MAIL
REFERENCE TO WARNING LETTER SEA 08-15

Food and Drug Administration
Attn: Michael J. Donovan
Compliance Officer
22201 23td Drive SE
Bothell, WA 98021-4421
425-483-4906 Tel

RESPONSE LETTER

Dear Michael,

In response to the inspection performed on March 1lth and 12th, 2008, Western United Fish Company has made all necessary corrective actions to comply with FDA's HACCP and Current Good Manufacturing Practice regulations. Furthermore, we have hired a seafood quality specialist, [redacted], for consultations regarding this matter and help make corrections to our HACCP plan in order to comply with FDA's seafood HACCP regulations.

Corrective Actions

We have ordered a new digital high temperature continuous monitoring system that is accessible via internet and will alert and email when temperatures reach beyond its set point. The frequency of this monitoring system will be 24 hours/day, 7 days/week. Data loggers will be downloaded, reviewed, and filed at the end of each week.

We will continue to perform daily visual temperature inspections three times per day for our coolers and freezers. Each time, we will verify the temperature on the data logger with a separate thermometer and record it on our daily temperature recording logs.

Under our HACCP plan for Scombroid Species, the corrective actions for receiving will include:

• Reference per 123.7C

Under our HACCP plan for Scombroid Species, the corrective actions for storage will include:

• Reference per 123.7C

Please let me know if you have any questions.

Sincerely,

/S/

John Nguyen
HACCP Coordinator
Western United Fish Company
9411 8th Avenue South Suite 1
Seattle, WA 98108
206-763-1227 Office
206-763-2048 Fax
425-443-8122 Mobile

9411 8th Avenue South, Suite 1 Seattle, WA 98108
phone 206.763.1227 fax 206.763.2048 www.westernunitedfish.com