1Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
Inspection Record
Elvium Life Sciences — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The assessment to release finished products was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Other quality system
The availability or the content of the authentic certificate of analysis was inadequate. The evidence required to demonstrate compliance with finished product specifications was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-01. 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.
