1Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
Inspection Record
Medline Canada Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The written specifications were inadequate.
3Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Equipment 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.
8Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
9Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
10Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-12. 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.
