CLOSEOUT LETTER
Rontis Hellas S.A. MARCS-CMS 695160 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameMr. Anastasios Politopoulos
-
Recipient TitleCEO
- Rontis Hellas S.A.
Rontis Hellas S.A. Industrial Area of Larissa
41500 Larissa, Thessaloniki
Greece
- Issuing Office:
- Center for Devices and Radiological Health
United States
United States
Dear Mr. Anastasios Politopoulos:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #695160 dated October 28, 2024). Based on our evaluation of the evidence provided in your Warning Letter response #5 (received by FDA on December 31, 2025), 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/
for Bram Zuckerman, MD
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Jessica Osward-McLeod
Nipro Medical Corporation
3150 NW 107th Ave.
Miami, Florida 33172, USA
jessicao@nipromed.com