1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
KYE Pharmaceuticals 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 recorded information or details were inadequate.
3Equipment 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.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory.
6Complaint and recall handling
The written recall system did not include distribution records that allowed each drug to be traced.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-08. 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.
