Inspection Record

Aurobindo Pharma Ltd. (Unit VII) — Health Canada Inspection Findings

Health CanadaInspected 2022-09-19 4 findingsComputer system validationQuality unit oversightDeviation, CAPA, and investigationOther quality system

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

Findings

1Computer system validation

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

2Quality unit oversight

The annual product quality review procedure was inadequate.

3Deviation, CAPA, and investigation

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

4Other quality system

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-09-19. 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.

Aurobindo Pharma Ltd. (Unit VII) company profile — full history Health Canada documents, 2022 Go to Findings search