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Medtronic MiniMed

Medtronic MiniMed

United States

Issuing Office:

United States


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

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

DEC 29, 2014


Mr. Hooman Hakami
Medtronic MiniMed
18000 Devonshire Street
Northridge, CA 91325-1219

Dear Mr. Hakami,

The Food and Drug Administration has completed an evaluation of your firm's corrections and corrective actions in response to our Warning Letter (CMS case # 405884) dated September 19, 2013. 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 yours,

Alberto Gutierrez -S

Alberto Gutierrez
Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and Radiological Health


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