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CLOSEOUT LETTER

Medinol Ltd. Feb 11, 2015

Medinol Ltd. - Close Out Letter 2/11/15


Medinol Ltd.

  

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 

FEB 11, 2015

Judith Richter, Ph.D.
Chief Executive Officer
Medinol, Ltd.
Bech Tech Building
Har Hotzvim, P.O. Box 45026
91450 Jerusalem
Israel

Dear Dr. Richter:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the Warning Letter (CMS # 434410, dated July 29, 2014). Based on our evaluation, it appears that your firm has addressed the violation 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 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. 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/
Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health