Curasan AG, Frankfurt Facility

CLOSEOUT LETTER Curasan AG, Frankfurt Facility MARCS-CMS 534581 — June 03, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Michael Schlenk Recipient Title Chief Executive Officer Curasan AG, Frankfurt Facility Lindigstrse 4 63801 Kleinostheim Germany Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Schlenk: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #534581, dated August 23, 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/ Keisha R. Thomas, MS, MHS, RAC Deputy Director Division of Premarket and Labeling Compliance Office of Compliance Center for Devices and Radiological Health CC: Ray Shane 3200 Chapel Hill-Nelson Blvd. Suite 201 Research Triangle Park, NC 27709 Content current as of: 05/24/2022 Regulated Product(s) Medical Devices