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CLOSEOUT LETTER

King Mountain Tobacco Company, Inc. Aug 02, 2016

King Mountain Tobacco Company, Inc. - Close Out Letter 8/2/16


King Mountain Tobacco Company, Inc.

  

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

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

VIA USPS

AUG 02 2016
 

Delbert Wheeler
King Mountain Tobacco Company, Inc.
P.O. Box 422
White Swan, WA 98952-0422


Dear Mr. Wheeler:

The United States Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has completed an evaluation of your corrective actions following the issuance of FDA's Warning Letter dated October 30, 2014. Based on our evaluation, it appears that you are addressing the violations contained in the Warning Letter by taking action towards fulfilling your past and current user fee obligations, as well as by taking steps to prevent similar violations from reoccurring in the future. Specifically, you have routinely made payments towards the firm's arrearage while timely paying recent quarterly assessments.

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. This letter also will not preclude any regulatory action should FDA become aware of any failure to pay assessed user fees or should FDA observe any other violations in the future.

Sincerely,

/S/

David Keith
Division Director
Division of Enforcement and Manufacturing
Office of Compliance and Enforcement
Center for Tobacco Products


VIA Electronic Mail

cc:

Kelli J. Keegan
Johnson Barnhouse & Keegan LLP
kkeegan@indiancountrylaw.com