East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility in Karlskoga, Sweden. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP). One Form 483 observation was issued during the inspection, which has been satisfactorily resolved. The US FDA authorities inspected the facility in March 2014.
Bjarne Sandberg, Managing Director of Cambrex Karlskoga remarked, “We are very pleased with the result of this US FDA inspection. An exceptional regulatory compliance track record is very important to us and our customers. We continuously strive for the highest quality standards and platforms within Cambrex.”
The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by the US FDA. This follows successful inspections at Cambrex Karlsoga made previously by MPA (Sweden) in September 2013 and November 2010, and the US FDA in January 2011.