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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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www.mangga-dua.com - Close Out Letter 6/15/12

  

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

 

JUN 15, 2012

VIA Electronic Mail


Yongke Kurniawan
yongke159@yahoo.com
cs@mangga-dua.com
marketing@manqqa-dua.com

Dear Mr. Kurniawan:

The Food and Drug Administration's Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated June 1, 2012. Based on our evaluation, it appears that you have addressed the violation contained in the Warning Letter by no longer offering for sale flavored cigarettes on http://www.mangga-dua.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
Group Leader
Promotion, Advertising, and Labeling Group
Office of Compliance and Enforcement
Center for Tobacco Products

 


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