FDA 483 - Hovione FarmaCiencia SA - June 28, 2024

Hovione Farmaciencia SA, a drug manufacturer in Loures, Lisbon, Portugal, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequately qualified production equipment, insufficient investigation of manufacturing discrepancies, and a failure to maintain adequate production and process control procedures. Additionally, the firm was cited for issues with instrument calibration and qualification, and for not verifying the reliability of raw material supplier analyses.