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CLOSEOUT LETTER

Seamus LLC


Seamus LLC

  

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

 
 Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
         FAX: (410) 779-5707

FEI: 3010099388


WARNING LETTER CLOSE-OUT LETTER


June 16, 2016

Via UPS

Mr. Young H. Han, CEO
Seamus LLC
6965 Gateway Ct.
Manassas, VA 20109

Dear Mr. Han:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 445104, dated May 20, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. A follow-up inspection performed by the FDA revealed that your firm has discontinued processing all eel products that were cited in the Warning Letter. Please inform the FDA in the event your firm decides to process any fishery products in the future.

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 yours,

David P. Rice
Compliance Officer
Baltimore District