1Other quality system
The availability or the content of the authentic certificate of analysis was inadequate. Measures to ensure the compliance of the contracted test laboratories were inadequate.
Inspection Record
UniLab Analytical Services Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment 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.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate. The written protocol and/or the assessment of the test method transfer was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-02. 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.
