Inspection Record

Henkel Canada Corporation — Health Canada Inspection Findings

Health CanadaInspected 2023-04-17 11 findingsMaterial and supplier controlEquipment and facilityOther quality systemRegulatory reporting and change controlComplaint and recall handlingDeviation, CAPA, and investigationQuality unit oversightStability and storage

View the regulator's official source The source document is always the basis for judgement.

Findings

1Material and supplier control

The handling of rejected materials and products was inadequate.

2Equipment and facility

Evaluation of production processes, equipment, and/or materials was inadequate.

3Equipment 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.

4Other quality system

The handling of standard operating procedures for good manufacturing practices was inadequate.

5Other quality system

The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.

6Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

7Complaint and recall handling

The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.

8Other quality system

The controls put in place for electronic signatures were inadequate.

9Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

10Quality unit oversight

The annual product quality review procedure was inadequate.

11Stability and storage

The temperature and/or humidity control was inadequate. The doors, windows, walls, ceilings, and/or floors were inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-04-17. 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.

Henkel Canada Corporation company profile — full history Health Canada documents, 2023 Go to Findings search