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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Arasys Perfector Inc - Close out letter

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

January 31, 2011

Dr. Xanya Sofra-Weiss
CEO, Director of R&D
Arasys Perfector, LLC
7773 Waikapu Loop
Honolulu, HI 96825
 

Dear Dr. Weiss:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated June 28, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve 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. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
 

Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health