1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
Bausch Health Companies 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 premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
6Material and supplier control
The protection of products and/or materials from contamination was inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-06-01. 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.
