1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
ICU Medical Canada 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 evidence required to demonstrate compliance with finished product specifications was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Stability 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.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Laboratory and QC controls
The quality control department did not undertake all of the required activities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-23. 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.
