US FDA issues Form 483 to Hovione API facility in Portugal

By Zachary Brennan

- Last updated on GMT

FDA issues Form 483 to Hovione in Portugal

Related tags Food and drug administration Fda

The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

The five day inspection carried out by investigators Ramon Hernandez and Jose Lopez Rubet still confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP), but the company did not disclose what the inspectional observations were.

"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​,” Luisa Paulo, Hovione's Compliance Director, said. “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​.”

Back in 2009, the same site was approved​ by the FDA without any deviations or Form 483s.

Earlier this year, Guy Villax, CEO of Hovione, also questioned the quality of products coming out of China and India​, noting that audit reports need to be shared more widely.  

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 Villax.

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