1Quality unit oversight
The quality control department did not evaluate the results of the annual product quality review.
Inspection Record
Edmonton Radiopharmaceutical Centre (Alberta Health Services) — 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.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Other quality system
The assessment to release finished products was inadequate.
5Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
6Deviation, 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.
7Other quality system
A document was not issued for each vendor verifying the vendor meets the criteria for certification.
8Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
9Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
10Other quality system
The company's visual inspection of filled containers was inadequate.
11Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
12Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-06-01. 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.
