1Equipment and facility
"The maintenance of records was inadequate.
Inspection Record
Stryker 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
The handling of standard operating procedures for good manufacturing practices was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Other quality system
The written self-inspection procedure was inadequate.
4Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
5Complaint and recall handling
The written procedures for recalls were inadequate. The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-11. 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.
