Inspection Record

Taro Pharmaceuticals Inc — Health Canada Inspection Findings

Health CanadaInspected 2025-03-24 6 findingsOther quality systemComputer system validationLaboratory and QC controlsCleaning validation

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

Findings

1Other quality system

The monitoring procedures for microbial and/or environmental conditions were inadequate.

2Computer system validation

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

3Laboratory and QC controls

The quality control department did not undertake all of the required activities.

4Other quality system

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

5Laboratory and QC controls

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

6Cleaning validation

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-03-24. 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

Taro Pharmaceuticals Inc company profile — full history Health Canada documents, 2025 Go to Findings search