1Material and supplier control
The procedures to prevent mix-ups between irradiated and non-irradiated materials were inadequate.
Inspection Record
Hetero Labs Limited — 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 closure system for the sterile product container was inadequate.
3Other quality system
The company's visual inspection of filled containers was inadequate.
4Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-02. 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.
