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Terragene S.A. MARCS-CMS 667432 —

Medical Devices

Recipient Name
Mr. Esteban Lombardia
Recipient Title
Terragene S.A.

Ruta Nacional N9
Km 280, CP 2130, Parque Industrial Micropi
2130 Alvear
Santa Fe

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.

Binita Ashar, M.D., M.B.A., F.A.C.S.
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health April 5, 2024

US AGENT: Benny Arazy
US AGENT ADDRESS: medes@arazygroup.com

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