Cane S.p.A.

CLOSEOUT LETTER Cane S.p.A. MARCS-CMS 453171 — March 06, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Claudio Cane Recipient Title Managing Director Cane S.p.A. Via Cuorgné, 42/a Rivoli 10098 Turin Italy Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Cane: 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 July 29, 2015. 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 yours, /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: 03/12/2020