1Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
Inspection Record
BC Cancer, part of the Provincial Health Services Authority — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Material and supplier control
The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
4Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
5Other quality system
The environmental sampling methods were inadequate.
6Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
7Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-11. 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.
