1Other quality system
The master production documents were inadequate.
Inspection Record
Nitrous Oxide Of Canada, A Division Of Red-D-Arc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Equipment 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.
4Complaint and recall handling
The written procedures for recalls were inadequate.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Laboratory and QC controls
The quality control department did not undertake all of the required activities. The system for reviewing, revising, and approving standard operating procedures was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
9Other quality system
The implementation of a self-inspection program was inadequate.
10Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented. The master formulas to control the manufacturing process were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-01. 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.
