Getsch+Hiller Medizintechnik GmbH

CLOSEOUT LETTER Getsch+Hiller Medizintechnik GmbH MARCS-CMS 644680 — September 20, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Tobacco Recipient: Recipient Name Mr. Werner M. Hiller Recipient Title Co-Owner Getsch+Hiller Medizintechnik GmbH Sattlerstrape 20 78532 Tuttlingen, Nendingen Germany werner.hiller@getsch-hiller.de Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Hiller: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS#644680, dated December 27, 2022). Based on our evaluation, it appears that you have addressed the violation(s) 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/ For, Binita S. Ashar, MD, MBA, FACS Director Office of Surgery and Infection Control Devices Office of Product Quality and Evaluation Center for Devices and Radiological Health Content current as of: 09/29/2023 Regulated Product(s) Tobacco