1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
Linde Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Other quality system
The implementation of a self-inspection program was inadequate.
5Complaint 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.
6Equipment 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.
7Deviation, CAPA, and investigation
The deviation investigations to reconcile bulk product or printed packaging materials were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-09. 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.
