Inspection Record

United Therapeutics Corporation — Health Canada Inspection Findings

Health CanadaInspected 2025-04-08 3 findingsContamination controlOther quality systemDeviation, CAPA, and investigation

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

Findings

1Contamination control

The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.

2Other quality system

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

3Deviation, CAPA, and investigation

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

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-04-08. 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.

Other records for this company

2024-02-20 · Health Canada · 3 findings2024-02-20 · Health Canada · 7 findings
United Therapeutics Corporation findings history — including this company's other documents Health Canada documents, 2025 Go to Findings search