1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The effectiveness of the training was not assessed by the firm.
Inspection Record
Bis Laboratories — 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 procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.
3Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The establishment and/or the maintenance of a data governance plan was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-12-16. 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.
