Inspection Record

Haemonetics Canada Ltd — Health Canada Inspection Findings

Health CanadaInspected 2022-02-24 3 findingsLaboratory and QC controlsDeviation, CAPA, and investigation

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

Findings

1Laboratory and QC controls

The quality control department's selection of a laboratory for testing and/or examination was inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

2Deviation, CAPA, and investigation

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

3Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate. The company's oversight of the contracted party was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-02-24. 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.

Haemonetics Canada Ltd company profile — full history Health Canada documents, 2022 Go to Findings search