Novasep Announces Successful FDA Inspection

Novasep has announced that its API development and manufacturing site in Chasse-sur-Rhône, France, has been successfully inspected by the US Food and Drug Administration.

The on-site inspection, carried out from June 18th to 22nd 2018, confirmed Novasep’s compliance with US pharmaceutical cGMP. Novasep’s Chasse-sur-Rhône site has an excellent FDA track record with the five last inspections free of any Form 483s. This continues a series of successful FDA inspections at Novasep’s CDMO sites. The Le Mans, Mourenx (France) and Leverkusen (Germany) sites also passed their latest FDA inspections without any 483s.

“I’m delighted with the excellent results of the last FDA inspections: it confirms Novasep’s continuous commitment to ensuring the highest quality standards for our global customers,” said Dr Michel Spagnol, chairman and chief executive officer of Novasep.

Since the beginning of 2018, Novasep also completed successful local health authorities’ inspections for both small molecules and biomolecules custom manufacturing sites: at Le Mans, France, in March 2018, by the ANSM (French National Agency for Medicines and Health Products Safety), and at Gosselies, Belgium, by the FAMHP (Federal Agency for Medicines and Health Products) in June 2018.

“These results reward the day-to-day involvement of each of our co-workers,” said Jean Bléhaut, president of Novasep’s Manufacturing Solutions Business Unit, “I would like to congratulate this teamwork, which enables Novasep to provide best-in-class CDMO services for both synthetic APIs and biologics.”

Novasep’s site in Chasse-sur-Rhône, France, produces APIs and advanced intermediates, mainly for late phase and commercial supply. The site recently commissioned significant expansions of its pilot plant and large scale cryogenic capacities.