Terragene S.A.

CLOSEOUT LETTER Terragene S.A. MARCS-CMS 667432 — April 05, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Esteban Lombardia Recipient Title CEO Terragene S.A. Ruta Nacional N9 Km 280, CP 2130, Parque Industrial Micropi 2130 Alvear Santa Fe Argentina Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Esteban Lombardia: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS case # 667432, dated November 01, 2023. 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/ Binita Ashar, M.D., M.B.A., F.A.C.S. Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health April 5, 2024 CC : US AGENT: Benny Arazy US AGENT ADDRESS: medes@arazygroup.com Content current as of: 06/28/2024 Regulated Product(s) Medical Devices