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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacific Northwest Best Fish Company Response Letter

MEMO

TO: Michael J. Donovan

CC:

FROM: Kelly Beckwith

DATE: 9/26/2005

RE: Request that the response be posted.


Dear Mr. Donovan,

Per our conversation, I am requesting that Pacific NW Best Fish Company's response is posted on the FDA website. Enclosed is a CD-ROM with our response letter.

Thank you again for your time.

Sincerely,

/s/

Kelly Beckwith

Pacific NW Best Fish Co.


August 5, 2005

Food and Drug Administration
Attn: Michael J. Donovan, Compliance Officer
22201 23rd Drive SE
Bothell, WA 98021

Dear Michael J. Donovan,

This is in response to the letter sent July 19th, 2005 by Charles Breen regarding Pacific NW Best Fish Company.

Pacific NW Best Fish Company has implemented recommendations suggested by the FDA as of April 1st, 2005.

The following recommendations have been addressed:

Observation #1 -
PNWB has re-organized and monitored all areas noted by the FDA as potential hazards. [redacted] also monitors activity of potential hazards through contract with PNWB, and records are kept on file.

Sanitation Standard Operating Procedures are being conducted weekly. Prior Violations have been addressed.

Observation #2 -
Sanitation records are taken weekly.
Clark County City Water records are kept on file.
Health Department Rating 98%.

Observation #3 -
[redacted] records have been updated and filed.

Observation #4 -
Smoking CCP has been calibrated by [redacted]
New Chart Recorder installed by [redacted]

Observation #5
New Chart Recorder installed by [redacted]
Calibration certificate on file from [redacted]

Observation #6
New monitoring system that calculates "cooked smoked product" from 145'F to (cooling) 40'F in 6 hrs. and less HACCP Plan paper work change.

Observation #7
HACCP Plan paper work change.

Observation #8
Product was not compromised . Time monitoring at Brining CCP addressed and more strictly enforced by staff.

Observation #9
HACCP Plan paper work change.

Observation #10
Kelly Beckwith, General Manager, HACCP Certified 03/05.
Jim Oswalt, Retail Manager, HACCP Certified 03/05.
All records have been signed and dated by a certified HACCP representative of PNWB as of 04/05.

Observation #11
HACCP Plan paper work change.

Observation #12
In the process of developing a "salmon jerky" HACCP program as recommended by the FDA .

Observation # 13
See Observation #10

Observation #14
See Observation #10

Thank you for the opportunity to response to the FDA recommendations and to provide you with documentation of corrective actions taken by Pacific NW Best Fish Company.

Sincerely,


Kelly Beckwith
General Manager
Pacific NW Best Fish Co.