1Equipment and facility
The maintenance of personnel records was inadequate.
Inspection Record
2156684 Ontario 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 implementation of a self-inspection program was inadequate.
3Complaint and recall handling
The written recall system did not include distribution records that allowed each drug to be traced. The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.
4Laboratory and QC controls
The quality control department did not undertake all of the required activities.
5Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
6Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-06. 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.
