The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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
The quality control department did not undertake all of the required activities.
Complete testing was not performed according to the requirements.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-11-25. 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.
