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 Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP). The US FDA authorities inspected the facility in late February 2012.
The entire facility and the quality systems used for the manufacture and release of APIs and food grade products were subject to a detailed compliance inspection. At the completion of the inspection no Form 483 observations were issued. This follows successful inspections made by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK October 2011, after which a GMP certificate for a drug product intermediate was issued, and a US FDA inspection conducted March 2010 during which no 483 observations were issued.
Joe Nettleton, Vice President Operations and Charles City Site Director commented, “We are very pleased with the results of the US FDA inspection and our other recent successful inspections by regulatory agencies. We work diligently to maintain high quality standards and we have once again demonstrated the results of our efforts to sustain and continuously improve quality platforms within Cambrex.”