The process was inadequate for the environmental classification of aseptic or clean areas.
Inspection Record
Centre for Probe Development and Commercialization — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The assessment to release finished products was inadequate.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-30. 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.
