Michael Conforti, DVM, MS, MBA
Vice President of Preclinical Operations
8945 Evergreen Blvd NW
Minneapolis, MN 55433-6043
Dear Dr. Conforti:
The purpose of this letter is to inform you that the Food and Drug Administration (FDA) inspection conducted at your clinical site from May 10, 2021 to May 21, 2021 revealed no significant concerns. The FDA has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated February 12, 2019. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL and has implemented the corrective actions, as promised in your response letters, dated October 25, 2018, November 9, 2018, November 30, 2018, December 11, 2018, March 1, 2019, April 8, 2019 and June 14, 2019.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sheena A. Green, MS
DCEA1: Division of Clinical Science and
OCEA: Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health