Another Successful FDA Inspection at a Hovione Site

Hovione's plant in Loures, Portugal has successfully passed a GMP and Postmarket Approval inspection by FDA.

The inspection, done by Mrs Yumi Hiramine, Inspector from CDER, lasted 5 days as initially planned, starting on 23 September and concluded on the 27 September. No Form 483 was issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP System, inspection organisation and the knowledge of its team members.

“We are pleased to have another successful FDA inspection at our Loures plant completed," said Guy Villax, Hovione’s CEO. "Doing well in the eyes of an FDA inspector is always a motive of satisfaction and a good reason to congratulate one’s team — well done!; but with 65 client audits and inspections per year our sites are always inspection-ready”.

Hovione’s five plants were the object of 12 inspections in the last 18 months. These inspections were performed by some of the world’s major Health Authorities:

•         Five by the US FDA in Portugal, Ireland  Macau and New Jersey — 4 of them with no Form 483 issued

•         Three by the Portuguese Health Authority (INFARMED) in Portugal, Macau and China, which led to GMP certificates granted to each of the sites;

•         One by the Irish Medicines Board (IMB) in Hovione's Cork plant, which ended with the issuance of GMP certificates;

•         One by the Korean FDA in the Portuguese plant;

•         Two by the CFDA in China.

Luisa Paulo, Hovione’s Compliance Director said: “The main objective of theses inspections was to evaluate how the guidelines and internal procedures are followed in day-to-day plant operations. Special emphasis was given to how the company records and manages OOS, deviations, change control, batch production records, complaints, validation and product quality reviews. The Inspectors were always pleased to see consistency between daily practice and the quality system.”