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Home / About Novasep / Media & Events / Press releases / Novasep Custom Manufacturing Site Passes Fifth Consecutive FDA Inspection Without 483s

Novasep Custom Manufacturing Site Passes Fifth Consecutive FDA Inspection Without 483s

Novasep Custom Manufacturing Site Passes Fifth Consecutive FDA Inspection Without 483s
21 Aug 2018

Novasep’s robust quality assurance system, fully compliant with the highest world standards, showcased during successful FDA inspection of the Chasse-sur-Rhône (France) facility.

Lyon, France, August 27, 2018 – Novasep, a leading supplier of services and technologies for the life sciences industry, is proud to announce that its API development and manufacturing site in Chasse-sur-Rhône, France, has been successfully inspected by the US Food and Drug Administration (FDA).

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 CEO 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.

About Novasep

Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life sciences molecules and fine chemicals. Novasep's unique offering includes process development services, purification equipment and turnkey processes, contract manufacturing services and complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food and functional ingredients as well as fermentation and chemical commodities industries.

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Laure Saloin
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+33 7 77 94 37 52

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