F. Hoffmann - La Roche Ltd. – FDA 483, Aug 5, 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.
ID · 05362655-43dd-4e12-8b22-81f7713de50d
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.