1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions 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
2Equipment and facility
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Other quality system
Periodic confirmatory testing was not conducted.
5Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
6Material and supplier control
Bulk drugs, in-process drugs, raw materials, or packaging materials were not labelled with all the required information.
7Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Material and supplier control
The sampling plan for raw materials was inadequate.
10Equipment 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-08. 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.
