- Delivery Method:
- VIA Electronic Mail
- Medical Devices
Recipient NameRobert “Bobby” A. Kasprzak
Recipient TitleChief Executive Officer
- Innova Medical Group, Inc.
800 E. Colorado Blvd.
Pasadena, CA 91101
- Issuing Office:
- Center for Devices and Radiological Health
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.
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Cc: Douglas W. Woodruff, Chief Regulatory, Quality, and Clinical Affairs Officer, Innova Medical Group,
Morris L. Young, Vice President of Quality, Innova Medical Group, Inc.