1Other quality system
Documents were not available on the premises.
Inspection Record
Kenvue Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Laboratory and QC controls
The quality control department did not undertake all of the required activities.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Laboratory and QC controls
The company did not adequately validate the analytical test procedures used in the stability program.
9Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
10Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
11Other quality system
The production areas were not restricted to designated staff only.
12Stability and storage
The temperature and/or humidity control was inadequate.
13Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
14Deviation, CAPA, and investigation
The creation, maintenance, processing, and/or review of laboratory data was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-19. 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.
