Inspection Record

Kora Healthcare Canada Inc. — Health Canada Inspection Findings

Health CanadaInspected 2024-04-15 3 findingsRegulatory reporting and change controlStability and storageDeviation, CAPA, and investigation

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

Findings

1Regulatory reporting and change control

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

2Stability and storage

The ongoing stability program for a drug was inadequate.

3Deviation, CAPA, and investigation

The assessment to release finished products was inadequate. 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 2024-04-15. 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.

Kora Healthcare Canada Inc. company profile — full history Health Canada documents, 2024 Go to Findings search