CLOSEOUT LETTER
MicroVention Costa Rica S.R.L. MARCS-CMS 643188 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameAlberto Meseguer
-
Recipient TitleVice President and General Manager
- MicroVention Costa Rica S.R.L.
Coyol Free Zone, Building B33
Alajuela
20101
Costa Rica-
- Alberto.Meseguer@microvention.com
- Issuing Office:
- Center for Devices and Radiological Health
United States
United States
Dear Mr. Meseguer:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 643188, dated September 30, 2022). 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/
for Bram Zuckerman, M.D.
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Scafford Serron
35 Enterprise
Aliso Viejo, CA 92656
Scafford.Serron@microvention.com