Form 483 issued to Hovione API facility in Portugal
US FDA carried out a pre-approval inspection at Hovione API facility in Loures, Portugal covering two NDA filings. The inspection was carried out for 5 days by investigators named Ramon Hernandez and Jose Lopez Rubet .The site has been given three observations in the form 483.This site was previously approved in 2009 by the FDA without any deviations or Form 483s.
According to the Compliance Director of the company Luisa Paulo, “Addressing the observations is the top priority of the site management and the points raised will be replied within 15 working days from the receipt of the form 483.The director also said that the company is taking the observations on a positive note in order to improve the quality system at the Hovione facility as well as at other sites.