1Equipment and facility
The maintenance of records was inadequate.
Inspection Record
Laboratoire Léo Désilets M.H. Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Laboratory and QC controls
The quality control department did not undertake all of the required activities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-20. 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.
