1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The master production documents were inadequate.
Inspection Record
IMCD Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The maintenance of personnel records was inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
5Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The controls put in place for electronic signatures were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-28. 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.
