1Aseptic processing and sterility assurance
The company's monitoring and documentation of moist heat sterilization cycles was inadequate.
Inspection Record
Grifols Canada Therapeutics Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The company's visual inspection of filled containers was inadequate.
3Aseptic processing and sterility assurance
The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
4Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-10-06. 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.
