1Equipment 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.
Inspection Record
Medisca Pharmaceutique 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 availability or the content of the authentic certificate of analysis was inadequate.
3Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-18. 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.
