Inspection Record

Boehringer Ingelheim (Canada) Ltd Ltee — Health Canada Inspection Findings

Health CanadaInspected 2025-03-03 4 findingsDeviation, CAPA, and investigationQuality unit oversightStability and storageOther quality system

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

Findings

1Deviation, CAPA, and investigation

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

2Quality unit oversight

The annual product quality review procedure was inadequate. The quality control department did not evaluate the results of the annual product quality review.

3Stability and storage

The ongoing stability program for a drug was inadequate.

4Other quality system

The evidence required to demonstrate compliance with finished product specifications was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-03-03. 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.

Boehringer Ingelheim (Canada) Ltd Ltee company profile — full history Health Canada documents, 2025 Go to Findings search