1Other quality system
Containers were not cleaned or labelled when they were received.
Inspection Record
ICU Medical 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 company's visual inspection of filled containers was inadequate.
3Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
6Computer system validation
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
8Equipment and facility
The maintenance of the premises was inadequate.
9Cleaning validation
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The validation of test methods was inadequate.
10Laboratory and QC controls
The validation of test methods was inadequate.
11Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
12Material and supplier control
The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-06. 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.
