Inspections, Compliance, Enforcement, and Criminal Investigations
Omega Nutrition U.S.A., Inc. - Close Out Letter 12/15/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
December 15, 2011
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.
Charles M. Breen
cc: Philip C. Fraley, Operation Manager
Washington State Department of Agriculture