1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Argus Laboratory 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 usage logs for the equipment used for significant processing and/or testing operations were inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
5Laboratory and QC controls
The validation of test methods was inadequate.
6Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
7Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-14. 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.
