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CLOSEOUT LETTER

Tubilux Pharma Spa MARCS-CMS 523119 —

Reference #:
320-17-41

Recipient:
Recipient Name
Emidio Fedeli
Recipient Title
President and CEO
Tubilux Pharma Spa

Via Costarica 20/22
00071 Rome
Italy

Issuing Office:
Division of Drug Quality II

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Mr. Fedeli:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-41 dated July 6, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this 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 FDA 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,
/S/
LCDR Matthew Schnupp, PharD.
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
CDER/Office of Compliance