Portuguese contract manufacturer Hovione announces the results of every inspection, and generally, they come off with little drama. The latest FDA visit to its plant in Loures, Portugal, for a preapproval inspection, however, resulted in a Form 483 with three observations.
"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 in a statement. "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."
In addition to the plant in Portugal, the company has FDA-approved sites in the U.S., China, and Ireland. In its last three FDA inspections, two last year and one in 2011, the company said it has not received any Form 483 observations.
This was a preapproval inspection for two NDA filings, Hovione said. Any missteps in a plant during a preapproval inspection can keep a product from getting an FDA nod. Problems with a non-U.S. plant operated by the active pharmaceutical ingredient maker (API) for North Carolina-based Pozen have resulted in it getting a second complete response letter for a pair of cardio drugs awaiting FDA action. The company said Wednesday that it believes the issues have been resolved by the API provider but that the FDA's compliance division has been unable to reinspect the facility to make its own assessment.
- here's the release