1Other quality system
The implementation of a self-inspection program 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
2Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
3Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
4Computer system validation
The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Other quality system
The company's visual inspection of filled containers was inadequate.
6Environmental monitoring
The number of samples taken for environmental monitoring was insufficient.
7Training and personnel
Warning systems did not alert personnel when air pressure fell below established limits.
8Laboratory and QC controls
The quality control department's access to adequate facilities, trained personnel, materials, and/or equipment was inadequate to fulfill its duties and responsibilities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-04. 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.
