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FDA completes an inspection of Cambrex's API manufacturing facility in Charles City, Iowa.
Cambrex reported that FDA completed an inspection of Cambrex’s API manufacturing facility in Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of GMP and no Form 483 observations were issued. FDA authorities inspected the facility from July 31 to August 2, 2013.
This follows successful inspections at Charles City made previously by 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 of the UK October 2011, after which a GMP certificate for a drug product intermediate was issued.