Carbogen Amcis AG’s Bubendorf, Switzerland API manufacturing site has successfully completed a routine FDA inspection. The cGMP audit for several commercial products, as well as a Pre-Approval Inspection (PAI) for another program, was completed in September 2011. The audit involved an analysis of all systems, procedures and processes related to the development, validation and manufacture of APIs and highly-potent APIs at the site. The inspection was concluded with no Form 483 observations or maj...