Hovione’s Loures Facility Completes Successful FDA Inspection

FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.  

Hovione announced that the US FDA has performed a pre-approval inspection of its facility in Loures, Portugal, covering two new drug application (NDA) filings. The site was confirmed to be GMP-compliant.

FDA issued a Form 483 with three inspectional observations after the five-day inspection, conducted by FDA investigator Mr Ramon Hernandez and by Mr Jose A. Lopez Rubet, a chemist.

On the outcome of the inspection, Luisa Paulo, Hovione's compliance director, said in a press release, "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.”

Source: Hovione