Inspection Record

Estée Lauder Cosmetics Ltd. — Health Canada Inspection Findings

Health CanadaInspected 2022-03-21 11 findingsTraining and personnelEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationComputer system validationComplaint and recall handlingOther quality systemMaterial and supplier controlStability and storage

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

Findings

1Training and personnel

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.

2Equipment and facility

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

3Laboratory and QC controls

The written protocol and/or the assessment of the test method transfer was inadequate.

4Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

5Computer system validation

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

6Complaint and recall handling

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

7Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

8Other quality system

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

9Material and supplier control

The drug fabricator's specifications for raw materials were inadequate.

10Equipment 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.

11Stability and storage

The temperature and/or humidity control was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-03-21. 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.

Other records for this company

Estée Lauder Cosmetics Ltd. company profile — full history Health Canada documents, 2022 Go to Findings search