DRG Instruments GmbH

CLOSEOUT LETTER DRG Instruments GmbH MARCS-CMS 522669 — July 01, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Dr. Bernd Rӧder Recipient Title Head of Regulatory Affairs DRG Instruments GmbH Frauenbergstraβe 18 35039 Marburg Germany Issuing Office: "OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality" United States Dear Dr. Rӧder: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 522669, dated 10/17/2017). 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 yours, /S/ Courtney H. Lias, Ph.D. Deputy Director for Patient Safety and Product Quality OHT7: Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health CC: Ina Hairston DRG International, Inc. 841 Mountain Avenue Springfield , NJ US 07081 Email: qa@drg-international.com Content current as of: 07/28/2020 Regulated Product(s) Medical Devices