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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wayan Sumartini Saraswati - Close Out Letter 8/25/11


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

AUG 25 2011

VIA UPS and Electronic Mail

Wayan Sumartini Saraswati
c/o Nyoman Manik Ariyasa
Br. Tebongkang Singakerta Ubud,
Gianyar, Bali, 80511, ID

Dear Sir or Madam:

FDA's Center for Tobacco Products has completed an evaluation of your corrective actions in response our Warning Letter dated July 13, 2011. Based on our evaluation, it appears that you have addressed the violation(s) contained in the Warning Letter by no longer offering for sale your clove cigarettes on http://www.balicigarette.com and http://www.clovecigarettesmarket.com to customers in the United States. Specifically, you deleted the "USA" as a shipping option on both websites.

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.



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