Inspection Record

Eurofins CDMO Alphora Incorporated — Health Canada Inspection Findings

Health CanadaInspected 2024-10-22 3 findingsMaterial and supplier controlCleaning validationStability and storage

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

Findings

1Material and supplier control

The standard operating procedures or records for shipping and receiving raw materials were inadequate.

2Cleaning 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.

3Stability and storage

The temperature and/or humidity control was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-10-22. 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

Eurofins CDMO Alphora Incorporated findings history — including this company's other documents Health Canada documents, 2024 Go to Findings search