FDA 483 - Hovione LLC - January 22, 2020

Hovione LLC, a manufacturer of Intermediates and Active Pharmaceutical Ingredients in East Windsor, NJ, was cited for two significant observations. The inspection revealed inadequate employee training, which was identified as the root cause for a substantial number of quality-related events. Additionally, the firm failed to thoroughly review unexplained discrepancies, including the use of incorrect or expired solutions in analytical testing.