1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Bausch Health, Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The ongoing stability program for a drug was inadequate.
3Equipment 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.
4Other quality system
The recorded information or details were inadequate.
5Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
6Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
7Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-09-09. 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.
