Inhalation particle design and manufacturing specialist Hovione has announced the completion of an FDA GMP and postmarket approval inspection of its manufacturing plant in Loures, Portugal. According to the company, no Form 483 was issued after the 5-day inspection, which was completed on September 27, 2013, and the inspector “informed that she was satisfied with what she had seen and complimented Hovione on its GMP System, inspection organization and the knowledge of its team members.”
Hovione CEO Guy Villax commented, “We are pleased to have another successful FDA inspection at our Loures plant completed. 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.”
The company said that its five manufacturing facilities have been inspected twelve times in the past eighteen months. In addition to the Portuguese plant, Hovione operates plants in the US, Ireland, Macau, and China.
·Compliance Director Luisa Paulo stated, “the main objective of these 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.”
Read the Hovione press release.
