The CMO Novasep reports that FDA has successfully audited two of its European custom-manufacturing sites in Le Mans, France and Leverkusen, Germany. FDA investigators audited the two facilities in June and July 2013.
The FDA audit at the Novasep site in Le Mans was a pre-approval inspection for production of paclitaxel, a long-established anticancer parenteral active ingredient for which Novasep is a supplier. Novasep has held European Certificate of Suitability for paclitaxel since 2011 and an FDA drug master file since 1996.
The Leverkusen facility audit included both a pre-approval inspection of the production of formulated nitroglycerine and an overall cGMP inspection on all products made for the US market.