1Laboratory and QC controls
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative.
Inspection Record
Aralez Pharmaceuticals Canada 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 master production documents were inadequate.
3Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Other quality system
The assessment to release finished products was inadequate.
8Stability and storage
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-16. 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.
