1Equipment and facility
The maintenance of personnel records was inadequate.
Inspection Record
Unilever Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Computer system validation
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
6Other quality system
The assessment to release finished products was inadequate.
7Other quality system
The implementation of a self-inspection program was inadequate.
8Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
9Complaint and recall handling
The written procedures for recalls were inadequate.
10Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
11Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
12Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-03-21. 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.
