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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Faci S.P.A Closeout Letter 6/14/12

   

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

 Public Health Service
Food and Drug Administration
 

Silver Spring, MD 20993 


June 14, 2012


Mr. Franco Rossi
Faci S.P.A
Via Privata Devoto, 36
Carasco, GE 16042, Italy


Dear Mr. Rossi:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 300-12-010 dated May 24, 2012. Based on our evaluation, it appears that you have 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/
Douglas Stearn
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research

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