TriMed, Inc.

CLOSEOUT LETTER TriMed, Inc. MARCS-CMS 494255 — October 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Medical Devices Recipient: Recipient Name David H. Medoff Recipient Title CEO TriMed, Inc. 27533 Avenue Hopkins Santa Clarita , CA 91355 United States Issuing Office: Center for Devices and Radiological Health 19701 Fairchild Irvine , CA 92612 United States Dear Mr. Medoff: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated June 30, 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/ Jamie M. Bumpas Acting Director, Compliance Branch Content current as of: 10/21/2019 Regulated Product(s) Medical Devices