By Country
at manufacturing sites in this country 41 findings drawn from 7 published documents. The most recent cases are below; the full set is in search.
See all France findingsThe written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.
See every finding in this document View the regulator's official sourceProcedures for the control of storage areas and stock rooms have not been adequately established.
See every finding in this document View the regulator's official sourceFailure to submit a biological deviation report.
See every finding in this document View the regulator's official sourceAn MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
See every finding in this document View the regulator's official sourceIn-process inspections, tests, or other verification activities and approvals were not documented.
See every finding in this document View the regulator's official sourceRisk analysis is inadequate and is incomplete.
See every finding in this document View the regulator's official sourceThese findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-10-20, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
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