Grams Medical Inc.

CLOSEOUT LETTER Grams Medical Inc. MARCS-CMS 482761 — March 28, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Grams Medical Inc. United States Issuing Office: United States Office of Medical Device and Radiological Health Operations Division 3West 19701 Fairchild Irvine, CA 92612 VIA UNITED PARCEL SERVICE 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. Sincerely, /S/ Kelly D. Sheppard Director, Compliance Branch Content current as of: 05/11/2018