1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The controls put in place for electronic signatures were inadequate.
Inspection Record
Arkema Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The handling of standard operating procedures for good manufacturing practices was inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Other quality system
The implementation of a self-inspection program was inadequate.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
6Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-10-30. 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.
