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  5. Innova Medical Group, Inc. - 614819 - 10/21/2022
  1. Warning Letters

CLOSEOUT LETTER

Innova Medical Group, Inc. MARCS-CMS 614819 —

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

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