Leventon S. A. U.

CLOSEOUT LETTER Leventon S. A. U. MARCS-CMS 560534 — February 28, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 03/04/2020 Regulated Product(s) Medical Devices