1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Novo Nordisk Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
3Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The temperature and/or humidity control was inadequate.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Training and personnel
The ongoing training of personnel was inadequate.
6Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Laboratory and QC controls
The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-13. 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.
