US FDA warns Cambrex on API facility in Milan, Italy

Cambrex Corporation has received a warning letter from the US Food and Drug Administration (FDA) relating to an inspection of the company's generic active pharmaceutical ingredient (API) manufacturing facility located in Milan, Italy in March 2009. The observations noted in the warning letter are primarily related to the collection and maintenance of certain laboratory data.

The company has already addressed a number of observations following the inspection and is fully committed to working with the FDA to resolve all of the outstanding issues expeditiously. While the warning letter indicated that until the company demonstrates that the observations have been corrected, the FDA may withhold approval of new applications or supplements listing the Milan, Italy facility as the API manufacturer, and may deny entry into the US of products manufactured at the site, the company anticipates satisfactorily responding to the letter within the time period prescribed by the FDA and correcting all observations.