Fda Innova Medical Group Closeout Letter 614819 2022 10 21
Summary
An FDA close-out letter, MARCS-CMS 614819, dated October 21, 2022, from the Center for Devices and Radiological Health to Robert "Bobby" A. Kasprzak, Chief Executive Officer of Innova Medical Group, Inc. The letter states that FDA has completed an evaluation of the firm's corrective actions in response to Warning Letter WL #614819 dated June 10, 2021, and that the firm appears to have addressed the violations for its manufacturing facilities in Pasadena, CA and Brea, CA (one listed as out of business) and for MPS Medical, Inc. in Brea, CA. It adds that future inspections will assess the adequacy and sustainability of the corrections and that the letter does not preclude future regulatory action. It is signed /S/ Jessica Mu, Director, Compliance Branch, Office of Medical Device and Radiological Health Operations, Division 3.
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Full text
# Innova Medical Group, Inc. — FDA Close-Out Letter (MARCS-CMS 614819) — October 21, 2022 **Delivery Method:** VIA Electronic Mail **Product:** Medical Devices **Recipient:** Robert "Bobby" A. Kasprzak, Chief Executive Officer, Innova Medical Group, Inc. **Address:** 800 E. Colorado Blvd., Suite 288, 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. 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); Morris L. Young (VP of Quality) **Content current as of:** 10/25/2022 **Regulated Product(s):** Medical Devices
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