1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Sterinova 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 education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.
3Other quality system
The airborne particle monitoring system was inadequate.
4Other quality system
The company's visual inspection of filled containers was inadequate.
5Material and supplier control
To confirm the shelf life of the drug, the company did not use at least three commercial-scale batches of the drug for every strength of the drug and the approved packaging material.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-14. 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.
