483
Roche Diagnostics GmbHFDA 483 - Roche Diagnostics GmbH - August 29, 2019
Record Details
Roche Diagnostics GmbH in Mannheim, Germany, was cited for failing to submit a Medical Device Report (MDR) within 30 days for a device malfunction. The inspection also found that the firm did not adequately investigate other complaints to determine reportability. This indicates issues with their post-market surveillance and complaint handling processes.
Open in Dashboard
ID · 9da37e28-334c-4e14-b8b6-43bef01ce192