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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Omega Nutrition U.S.A., Inc. - Close Out Letter 12/15/11

  

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

Public Health Service
Food and Drug Administration
 

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

December 15, 2011


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Robert Gaffney, President
Omega Nutrition U.S.A., Inc.
6515 Aldrich Road
Bellingham, Washington 98226

Dear Mr. Gaffney:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 11-11 issued to you on April 6, 2011. Based on our evaluation, 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 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/

Charles M. Breen
District Director

 

cc: Philip C. Fraley, Operation Manager
     Washington State Department of Agriculture
 


 

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