The U.S. FDA has performed a Pre-Approval Inspection at Hovione’s plant in Loures, Portugal, covering two NDA filings. The inspection lasted five days from December 1-5, and while it confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP), the FDA issued a Form 483 with three undisclosed inspectional observations.    On the outcome of the inspection, Luisa Paulo, Hovione’s Compliance Director, said “Addressing these observations is ...