East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that it has received a warning letter from the U.S. Food and Drug Administration (FDA) relating to an inspection of the 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.
Cambrex 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 Cambrex 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. Cambrex anticipates satisfactorily responding to the letter within the time period prescribed by the FDA and correcting all observations.
Cambrex noted that the observations cited in the warning letter pertain only to its Milan, Italy facility and do not relate to its other manufacturing facilities.