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
Aguettant Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
3Complaint and recall handling
The written procedures for recalls were inadequate. The written recall system did not include distribution records that allowed each drug to be traced.
4Other quality system
Documents were not available on the premises. The electronic system was not validated for its intended use. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Other quality system
The controls put in place for electronic signatures were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-08. 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.
