Hovione Passes FDA Inspection

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Hovione's plant in Portugal has successfully passed its twelfth FDA inspection in 18 months.

Hovione's plant in Loures, Portugal has passed a GMP and postmarket approval inspection by FDA. The inspection lasted five days as initially planned, and began on Sept. 23, 2013 was concluded on Sept. 27, 2013. At the closing meeting, the inspector was satisfied the company's GMP system, and the inspection was sucessful.

Hovione’s five plants were the object of 12 inspections in the last 18 months. These inspections were performed by health authorities, including five by FDA, three by the Portuguese Health Authority, one by the Irish Medicines Board, one by Korean health authorities, and two by China’s health authority.


Source: Hovione