I.T.S. GmbH

CLOSEOUT LETTER I.T.S. GmbH MARCS-CMS 422665 — July 01, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Wolfgang Auf Recipient Title CEO I.T.S. GmbH Autal 28 Lasnitzhohe 8301 Steiermark Austria Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Wolfgang Auf: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 422665, dated June 30, 2014). 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/ CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health cc: US Agent Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200TH St. Prior Lake, MN 5537 Content current as of: 07/10/2019 Regulated Product(s) Medical Devices