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  5. Cane S.p.A. - 453171 - 03/06/2020
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CLOSEOUT LETTER

Cane S.p.A. MARCS-CMS 453171 —


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