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 the top priority of the site management and the points raised will be replied to within 15 working days from the receipt of the Form 483. We are taking this result to improve our quality system both here and at our other sites. The investigators spoke positively of many of our initiatives.  We have a strong pipeline of products under development with new NDAs being filed in the next 12 months, and we need to work diligently to continue to deserve our clients’ trust.”
 
“We have a culture of quality that puts patient safety first. This shapes our behaviors and motivates us to improve. This is a Team effort, and I am very encouraged to see everyone so committed,” said Guy Villax, chief executive officer.