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
Terumo BCT (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
The ongoing stability program for a drug was inadequate. The company did not adequately validate the analytical test procedures used in the stability program.
3Complaint and recall handling
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
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.
6Stability 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.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-09-01. 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.
