FDA 483 - F. Hoffmann - La Roche Ltd. - August 05, 2022

F. Hoffmann - La Roche Ltd. in Kaiseraugst, Switzerland, a parenteral and solid dose drug manufacturer, was cited for deficiencies during an FDA inspection. The observations include inadequate investigations into unexplained discrepancies, particularly concerning foreign particles in drug products. Additionally, the firm's aseptic processing areas showed insufficient environmental monitoring and inadequate controls over microorganisms, including issues with operator protective equipment and cleaning procedures.