1Laboratory and QC controls
The quality control department did not undertake all of the required activities.
Inspection Record
VitalAire 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 availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Complaint and recall handling
The written procedures for recalls were inadequate.
5Equipment and facility
The maintenance of personnel records was inadequate.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The controls put in place for electronic signatures were inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate.
8Other quality system
The written self-inspection procedure was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-04. 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.
