Cambrex warned by US FDA over Italian API plant

New Jersey, USA-based Cambrex Corp has revealed that it received a warning letter from the Food and Drug Administration relating to an inspection of the company's generic active pharmaceutical ingredient 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 says it 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 Cambrex demonstrates that the observations have been corrected, the FDA may withhold approval of new applications or supplements listing the Milan facility as the API manufacturer, and may deny entry into the USA 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.

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.