1Other quality system
The company did not set appropriate alert and action limits for the results of particulate and microbiological monitoring.
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
2Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
6Environmental monitoring
The number of samples taken for environmental monitoring was insufficient.
7Stability 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-02. 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.
