Innova Medical Group, Inc.

CLOSEOUT LETTER Innova Medical Group, Inc. MARCS-CMS 614819 — October 21, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Robert “Bobby” A. Kasprzak Recipient Title Chief Executive Officer Innova Medical Group, Inc. 800 E. Colorado Blvd. Suite 288 Pasadena , CA 91101 United States rak@innovamedgroup.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Kasprzak: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #614819) dated June 10, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter for your manufacturing facilities located at 800 E. Colorado Blvd., Suite 288, Pasadena, CA; 495 N. Berry St., Brea, CA (Out of Business); and MPS Medical, Inc. at 785 Challenger St., Brea, CA. 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/ Jessica Mu Director, Compliance Branch Office of Medical Device and Radiological Health Operations Division 3 Cc: Douglas W. Woodruff, Chief Regulatory, Quality, and Clinical Affairs Officer, Innova Medical Group, Inc. Douglas.Woodruff@innovamedgroup.com Morris L. Young, Vice President of Quality, Innova Medical Group, Inc. Morris.Young@innovamedgroup.com Content current as of: 10/25/2022 Regulated Product(s) Medical Devices