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
Servier 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.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Other quality system
The company's oversight of the contracted party was inadequate.
5Laboratory and QC controls
The quality control department did not undertake all of the required activities.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-31. 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.
