1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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 preventative maintenance and repair of the equipment was inadequate.
3Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
4Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate. The recorded information or details were inadequate.
5Laboratory and QC controls
The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-08-29. 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.
