Hovione’s API plant in Cork, Ireland has successfully passed a pre-approval inspection by the U.S. FDA. The five-day inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP), with no Form 483 observations.
Luisa Paulo, Hovione's compliance director, said, "The pre-approval inspection was triggered by a client NDA filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an extremely satisfying result for our team and for our customers. The Hovione Team members have again demonstrated their commitment and ability to meet the highest quality standards in the manufacturing of APIs and pre-formulated drug products.”
Jim Harvey, Hovione’s general manager at the Cork site, said, “We are very proud of the result achieved during this flawless FDA inspection. I am very satisfied that the FDA inspector reported no observations and I want to congratulate the entire team. This is another important step for our site in Cork as it confirms our ability to comply with high engineering, manufacturing and quality standards across all of the Hovione sites.”