1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Carestream Medical ULC dba MedPro Respiratory Care — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Training and personnel
The ongoing training of personnel was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-04-12. 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.
