1Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
Inspection Record
Prestilux Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of personnel records was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
5Other quality system
The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The controls put in place for electronic signatures were inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-05-14. 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.
