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Regions :: Western Europe :: Italy

Cambrex Gets FDA Warning on Milan API Facility

10:25 PM MDT | August 24, 2009 | Deepti Ramesh

Cambrex (East Rutherford, NJ) says it has received a warning letter from the U.S. FDA, relating to the collection and maintenance of certain laboratory data at the company’s generic active pharmaceutical ingredients (API) manufacturing facility at Milan, Italy. The warning letter follows an FDA inspection of the Milan facility in March 2009. The warning letter indicated that until Cambrex corrects all the observations, the FDA may withhold approval of new applications or supplements listing the Milan facility as the API manufacturer, and products...

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