1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Hansamed Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Equipment and facility
The maintenance of records was inadequate.
4Other quality system
The implementation of a self-inspection program was inadequate.
5Complaint and recall handling
The written procedures for recalls were inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Equipment 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.
10Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
11Other quality system
Tests were not performed according to approved specifications.
12Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
13Other quality system
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-06. 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.
