The FDA audit at the Le Mans site was a pre-approval inspection for production of paclitaxel, an anticancer parenteral active ingredient. The audit demonstrates the team’s capability to handle highly potent active pharmaceutical ingredients (HPAPI), including paclitaxel. The Leverkusen facility audit included both a pre-approval inspection of the production of formulated nitroglycerine and an overall cGMP inspection on all products for the U.S. market.
“The FDA has tightened up its surveillance and audits,” said Michel Spagnol, chief executive officer at Novasep. “Adhering to regulatory requirements is critical, although it is becoming progressively more challenging across the industry. Our teams’ commitment to quality is impressive. I am very pleased with our continued track record in securing FDA inspection approval and the added assurance these successes give our global customers.”