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 major/critical findings.
 
“The positive conclusion to this latest FDA audit in Bubendorf fulfills our commitment to customers and to the highest standard of quality they expect from us,” said Mark Griffiths, chief executive officer of Carbogen Amcis. “The fact that we have successfully completed our latest FDA audit speaks to the consistency of quality we offer our customers and continues our long track record of successful regulatory audits. As we move forward, we will continue to pursue opportunities to improve the quality of our products and the safety of our manufacturing process.”