FDA 483 - Hovione FarmaCiencia SA - March 13, 2017

Hovione Farmaciencia SA, an API manufacturer in Loures, Portugal, was inspected and cited for multiple deficiencies. The inspection revealed significant issues with quality control unit procedures, including inadequate deviation investigations and recall processes. Additionally, the firm failed to maintain proper laboratory controls, ensure adequate employee training, correctly segregate rejected materials, and keep its manufacturing buildings in good repair.