1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Kuehne + Nagel Ltd. — 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.
3Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Computer system validation
The temperature and/or humidity control was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-10. 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.
