Hovione announces results of FDA pre-approval inspection

Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1 to December 5, 2014.

In October 2013, the company announced that it had completed a successful FDA inspection of the Loures facility with no Form 483 issued.

Hovione Compliance Director Luisa Paulo 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.”

CEO Guy Villax added, “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.”