1Stability and storage
The temperature and/or humidity control was inadequate. The recorded information or details were inadequate.
Inspection Record
Edgewell Personal Care Canada, ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Material and supplier control
The identification, quarantine, and/or disposal of rejected materials was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-19. 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.
