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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.serenawholesaler.com - Close Out Letter 12/6/13

  

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

 
 Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

 

VIA Electronic Mail


DEC 06, 2013


Rafiq P. Khoja & Freddie Patel
Serena Wholesale
unitedbrothersint@yahoo.com


Dear Mr. Khoja & Mr. Patel:

The United States Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated October 9, 2013. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter by no longer offering for sale tobacco products to customers in the United States and discontinuing smokeless tobacco product advertisements that do not comply with applicable requirements under the FD&C Act. Specifically, you it deleted the entire Tobacco Products section of your website, http://www.serenawholesaler.com.

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 violations be observed in the future.

 

Sincerely,

/S/

Ele Ibarra-Pratt
Division Director
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products


VIA Electronic Mail

cc:

Swamy Narayan
Narayan@ticg.us