Inspection Record

Coloplast Canada Corporation — Health Canada Inspection Findings

Health CanadaInspected 2021-09-08 6 findingsOther quality systemValidation and qualificationDeviation, CAPA, and investigationQuality unit oversightStability and storage

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

Findings

1Other quality system

The implementation of a self-inspection program was inadequate.

2Validation and qualification

Validation studies were not conducted in keeping with the predefined protocols.

3Deviation, CAPA, and investigation

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

4Quality unit oversight

The annual product quality review procedure was inadequate.

5Stability and storage

The ongoing stability program for a drug was inadequate.

6Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2021-09-08. 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.

Coloplast Canada Corporation company profile — full history Health Canada documents, 2021 Go to Findings search