Hovione Passes FDA PAI Inspection at Irish API Facility
Hovione reports that its active pharmaceutical ingredient (API) plant in Cork, Ireland has successfully passed a pre-approval inspection (PAI) by the US Food and Drug Administration (FDA).
The inspection lasted five days and started on July 21, 2014 and concluded on July 25, 2014. The inspection confirmed the site to be compliant with the principles and guidelines of good manufacturing practices (GMP), and no Form 483 observations were issued.
The PAI was triggered by a client new drug application (NDA) filing; it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline.
Source: Hovione