1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Labofine — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Laboratory and QC controls
The quality control department did not undertake all of the required activities.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Stability and storage
The temperature and/or humidity control was inadequate.
6Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
7Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
8Computer system validation
The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-05-12. 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.
