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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sorin CRM S.A.S.- Close Out Letter 2/29/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire
Silver Spring, MD 2099

FEB 29, 2012


Mr. Stefano Di Lullo, President
Sorin CRM S.A.S.
4 avenue Reaumur
92140 Clamart
France

Dear Mr. Di Lullo:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated November 6, 2009. 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 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/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health

 

cc: U.S. Agent
     Ms. Claudia Manikam
     Sarin CRM USA, Inc.
     14401 W. 65th Way
     Arvada, CO 80004