FDA Pre-Approval Inspection Success at Caponago

Jul 18, 2018
News > CordenPharma Caponago Completes Successful FDA Pre-Approval Inspection

News > CordenPharma Caponago Completes Successful FDA Pre-Approval Inspection

CordenPharma Caponago (IT) aseptic fill & finish commercial plant pre-filled syringe robotized line 1 weighing station

CordenPharma Caponago (IT) Aseptic Fill & Finish Commercial Plant Pre-Filled Syringe robotized filling line 1 weighing station.

CordenPharma is pleased to announce that in July 2018 our CordenPharma Caponago (IT) injectable manufacturing facility completed a wide Pre-Approval Inspection (PAI) conducted by the US FDA. The facility received an FDA 483 form, which was limited to a few minor observations. Accordingly, the FDA inspector proposed a Voluntary Action Indicated (VAI) status that would suggest approval for all the involved products addressed in the PAI, two of which are going to be manufactured in the new Aseptic Fill & Finish Line in CordenPharma Caponago.

Fabrizio Fiordigiglio, Managing Director of CordenPharma Caponago comments, “We are pleased with the outcome of the FDA PAI Inspection in July 2018 as it reflects our high level of professionalism and attention to cGMP regulatory compliance in all production and quality processes according to the laws and regulations of the United States Authorities.”