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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medical Compression System Ltd. - Close Out Letter 8/16/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

AUG 16 2012

 

 

Adi Dagan
Chief Executive Officer
Medical Compression System Ltd.
2 Ha-llan St.
Or-Aqiva
30600, Israel

Dear Mr. Dagan:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter number 222174, dated October 21, 2011. 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 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/

William C. MacFarland
Division of Enforcement B
Center for Devices and
Radiological Health