Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.
The inspection confirmed the site to be compliant with GMP principles and guidelines and no Form 483 observations were issued. At the closing meeting the inspector informed that she was satisfied with what she had seen and complimented Hovione on its GMP system, inspection organization and the knowledge of its team members.
Luisa Paulo, Hovione's compliance director, commented in a press release that while 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,” Paulo added.
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.”