483
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA 483, Aug 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.
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ID · 9da37e28-334c-4e14-b8b6-43bef01ce192
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