1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions 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
2Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
3Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
4Computer system validation
The temperature and/or humidity control was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
6Other quality system
The electronic system was not validated for its intended use.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-04-19. 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.
