Inspection Record

RXI Infinity — Health Canada Inspection Findings

Health CanadaInspected 2025-01-14 4 findingsDeviation, CAPA, and investigationStability and storageRegulatory reporting and change controlTraining and personnel

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate.

2Stability 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.

3Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

4Training and personnel

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-01-14. 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.

RXI Infinity company profile — full history Health Canada documents, 2025 Go to Findings search