Hovione has successfully passed a GMP and Postmarket Approval inspection by the FDA at its plant in Loures, Portugal. The inspection lasted five days and concluded September 27th with no Form 483 issued. The inspector was satisfied with Hovione’s GMP System, inspection organization, and its team members.
“We are pleased to have another successful FDA inspection at our Loures plant completed," said Guy Villax, Hovione’s chief executive officer. "Doing well in the eyes of an FDA inspector is always a motive of satisfaction and a good reason to congratulate one’s team. With 65 client audits and inspections per year our sites are always inspection-ready.”
Hovione’s five plants have successfully passed 12 inspections in the past 18 months by the US FDA in Portugal, Ireland, Macau and NJ; three by the Portuguese Health Authority (INFARMED) in Portugal, Macau and China, which led to GMP certificates; one by the Irish Medicines Board (IMB) at its Cork plant, which resulted in GMP certificates; one by the Korean FDA in the Portuguese plant; and two by the CFDA in China.