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  5. Leventon S. A. U. - 560534 - 02/28/2020
  1. Warning Letters

CLOSEOUT LETTER

Leventon S. A. U. MARCS-CMS 560534 —

Product:
Medical Devices
Recipient:
Recipient Name
Francesc Cuxart
Recipient Title
CEO
Leventon S. A. U.

Newton 18-2
Sint Esteve Sesrovires
08635 Barcelona
Spain

Issuing Office:
Division of Health Technology 3C

United States

Dear Mr. Cuxart:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated September 5, 2018. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.

This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Tina Kiang, Ph. D
Director
Division of Drug Delivery and General
Hospital Devices and Human Factors
Office of Gastrorenal, ObGyn, General
Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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