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Grams Medical Inc. MARCS-CMS 482761 —

Grams Medical Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



Office of Medical Device and Radiological Health Operations
Division 3West
19701 Fairchild
Irvine, CA 92612 


March 28, 2018

CMS Case ID: 482761

UPS Overnight

Guenter Grams, President and CEO
Grams Medical Inc.
2443 Norse Ave
Costa Mesa, California 92627

Dear Mr. Grams:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 24-16, dated March 17, 2016. Based on our evaluation, it appears that you have addressed the violation(s) 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.


Kelly D. Sheppard
Director, Compliance Branch 

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