Inspection Record

2253500 Alberta Inc. — Health Canada Inspection Findings

Health CanadaInspected 2025-02-03 3 findingsRegulatory reporting and change controlStability and storageComputer system validation

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 evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

3Computer system validation

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-02-03. 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.

Other records for this company

2023-12-05 · Health Canada · 11 findings
2253500 Alberta Inc. findings history — including this company's other documents Health Canada documents, 2025 Go to Findings search