1Other quality system
Critical production processes were not validated.
Inspection Record
B. Braun of Canada Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Quality unit oversight
The annual product quality review procedure was inadequate.
4Equipment and facility
The maintenance of personnel records was inadequate.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-06-02. 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.
