Cambrex Corporation has 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) and no Form 483 observations were issued. The US FDA authorities inspected the facility from July 31 to August 2, 2013.
Joe Nettleton, Vice President Operations and Charles City Site Director commented, “We are very pleased with the results of this latest FDA inspection, which further strengthens our track record of outstanding regulatory compliance. We commit significant resources and work diligently to maintain high quality standards and continuously improve quality platforms within Cambrex.”
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.
This follows successful inspections at Charles City made previously by the US FDA in March 2010 and February 2012, neither of which resulted in any issued 483 observations, the Korean FDA in January 2012 and 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.