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  5. 77 Elektronika Kft. - 458367 - 05/29/2020
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77 Elektronika Kft. MARCS-CMS 458367 —

Medical Devices

Recipient Name
Sandor Zettwitz
Recipient Title
Managing Director
77 Elektronika Kft.

Fehervari ut 98

Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"

United States

Dear Mr. Zettwitz:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #458367 dated October 8, 2015). 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,
Courtney H. Lias, Ph.D.
Deputy Director for Patient Safety and Product
Office of In Vitro Diagnostics and Radiological
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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