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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ribbon SRL Close out Letter 4/18/11

  

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

Public Health Service
Food and Drug Administration
 

CENTER FOR DRUG EVALUATION AND RESEARCH
Division of Manufacturing and Product Quality
International Compliance Team
10903 New Hampshire Avenue
Building #51, Room 4221
Sliver Spring, MD 20993
TELEPHONE: (301) 796-3334
FAX: (301) 847-8742 


18 April 2011


Ms. Maria Gobbi
General Manager
Fresenius Kabi Anti Invectives S.r.L. (formally: Ribbon SRL)
Via San Leonardo 23
45010 Villadose (Rovigo)
Italy


Reference: FEI3005479678


Dear Ms. Gobbi:


The Food and Drug Administration has completed an evaluation or your firm's corrective actions in response to our Warning Letter WL: 320-10-006 dated May 27, 2010. 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/
Maan Abduldayem
Compliance Officer
International Compliance Branch