1Laboratory and QC controls
The validation of test methods was inadequate.
Inspection Record
Winnipeg Regional Health Authority — 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.
3Equipment and facility
The maintenance of records was inadequate. The electronic system was not validated for its intended use.
4Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
5Other quality system
The importer and/or the distributor's compliance with the current master production documents and/or the marketing authorization was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-16. 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.
