1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Messer Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Training and personnel
The health requirements for personnel were not captured in a written procedure.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Equipment 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.
6Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
7Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures. The handling of standard operating procedures for good manufacturing practices was inadequate.
8Equipment and facility
Printed packaging materials were not stored in an area with restricted access. Evaluation of production processes, equipment, and/or materials was inadequate.
9Regulatory 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 2024-11-20. 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.
