Tecres S.p.A. MARCS-CMS 459252 — August 20, 2019

CLOSEOUT LETTER

• Delivery Method: UPS
• Product: Medical Devices

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• Recipient: Giovanni Faccioli; President; Tecres S.p.A.; Via Andrea Doria 6; Sommacapagna; 37066 Veneto VR; Italy

• Issuing Office: Center for Devices and Radiological Health; 10903 New Hampshire Avenue; Silver Spring, MD 20993; United States

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Dear Giovanni Faccioli:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 459252, dated August 14, 2015). Based on our evaluation, it appears that your firm has addressed the violation(s) 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 Agency 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/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC: US Agent
Cristine Brauer
Brauer Device Consultants, LLC.
7 Trail House Court
0Rockville, MD 20850