Inspection Record

B. Braun of Canada Ltd. — Health Canada Inspection Findings

Health CanadaInspected 2022-09-27 4 findingsEquipment and facilityOther quality systemQuality unit oversightRegulatory reporting and change control

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

2Other quality system

The handling of standard operating procedures for good manufacturing practices was inadequate.

3Quality unit oversight

The annual product quality review procedure was inadequate.

4Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-09-27. The source is available at the link above.

This is a record of that moment. 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 it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2026-06-02 · Health Canada · 6 findings
B. Braun of Canada Ltd. findings history — including this company's other documents Health Canada documents, 2022 Go to Findings search