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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Non-Invasive Monitoring Systems, Inc. - Close Out Letter 6/24/13

  

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

 

JUN 24, 2013

 

Marvin A. Sackner
President and CEO
Non-Invasive Monitoring Systems, Inc.
4400 Biscayne Boulevard
Miami, Florida 33137


Dear Mr. Sackner:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter EC100318, dated March 18, 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
Director
Division of Enforcement B
Office of Compliance
Center for Device and
   Radiological Health