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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacific American Fish Co., Inc. - Close Out Letter 3/11/10

   

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

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

March 11, 2010

 

 

Mr. Paul Huh, CEO
Pacific American Fish Co., Inc.
5525 South Santa Fe Avenue
Vernon, CA 90058

 

Dear Mr. Huh:

The Food and Drug Administration conducted an inspection at your Boston, MA facility on January 8, 2010 - January 20, 2010. The purpose of this inspection was to verify corrective actions in response to our Warning Letter NWE-05-10W dated October 16, 2009.

Based on our evaluation of this inspection it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,

/s/

Lori A. Holmquist
Compliance Officer
New England District Office
Augusta Maine Resident Post

 

 

cc: Mr. Dale Silva, Manager
Pacific American Fish Co., Inc.
8 FlO Kennedy Avenue, Unit?
Boston, MA 02210-2365