ELITech Group B.V.

CLOSEOUT LETTER ELITech Group B.V. MARCS-CMS 534429 — June 18, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Adriaan P. Intveld Recipient Title Manager Quality Assurance & Regulatory Affairs ELITech Group B.V. Van Rensselaerweg 4 Gelderland 6956 AV Spankeren Netherlands Issuing Office: "OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality" United States Dear Adriaan P. Intveld: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 534429, dated September 20, 2017). Based on our evaluation, it appears that your firm has addressed the violations contained in the 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 Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 06/12/2020 Regulated Product(s) Medical Devices