1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. The company did not take precautions to minimize contamination during all processing prior to sterilization.
Inspection Record
Thunder Bay Regional Health Sciences Centre — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
6Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
7Other quality system
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.
8Aseptic processing and sterility assurance
The company did not validate and/or monitor isolator technology. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-09-20. 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.
