Inspection Record

Zee Medical Canada — Health Canada Inspection Findings

Health CanadaInspected 2026-02-18 6 findingsLaboratory and QC controlsRegulatory reporting and change controlStability and storageOther quality systemDeviation, CAPA, and investigation

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

Findings

1Laboratory and QC controls

There was no evidence of a functioning and/or independent quality control department.

2Regulatory reporting and change control

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

3Stability and storage

The temperature and/or humidity control was inadequate.

4Laboratory and QC controls

The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.

5Other quality system

The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.

6Deviation, 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 2026-02-18. 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

Zee Medical Canada findings history — including this company's other documents Health Canada documents, 2026 Go to Findings search