1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Waymade Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The company's oversight of the contracted party was inadequate. The validation and/or the documentation of test methods was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
4Equipment 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.
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.
