QLRAD Netherlands

CLOSEOUT LETTER QLRAD Netherlands MARCS-CMS 510526 — November 16, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Arjen Winkel Recipient Title President and CEO QLRAD Netherlands HOSPIMED Rietveldstraat 22 Zwolle 8013RW Overijssel Netherlands awinkel@qlrad.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Winkel, The Food and Drug Administration has completed an evaluation of QLRAD’s corrective actions in response to our Warning Letter (CMS #510526, dated July 20, 2017). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. 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/ Robert Ochs, PhD Director OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: EA Winkel QLRAD Inc. HYH 9107 NW 105th Way Medley, Florida 33178 Content current as of: 11/18/2022 Regulated Product(s) Medical Devices