Inspections, Compliance, Enforcement, and Criminal Investigations
Ribbon SRL Close out Letter 4/18/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
18 April 2011
Ms. Maria Gobbi
Fresenius Kabi Anti Invectives S.r.L. (formally: Ribbon SRL)
Via San Leonardo 23
45010 Villadose (Rovigo)
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.
International Compliance Branch