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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cherokee Brands, LLC Close out Letter 2/10/11

  

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

Public Health Service
Food and Drug Administration
 

Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229 

FEB 10 2011


Nancyellen Keane
Troutman Sanders LLP
1001 Haxall Point
P.O. Box 1122
Richmond, VA 23219


Dear Ms. Keane:


FDA's Center for Tobacco Products has completed an evaluation of your client's (Cherokee Brands, LLC) corrective actions in response to our Warning Letter of December 14, 2010. Based on our evaluation, it appears that your client has addressed the violations contained in this Warning Letter. Future FDA investigations and regulatory activities will further assess the adequacy and sustainability of these corrections.


This letter does not relieve your client 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 your client to maintain compliance and will continue to monitor its state of compliance. This letter will not preclude any regulatory action should violations be observed in the future.
 

 

Sincerely,

/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products


cc: Cherokee Brands, LLC
     Cherokee Tobacco Company, LLC
     Firebird Manufacturing, LLC
     341 Main Street, Suite 302
     Danville, VA 24541