Inspection Record

Natco Pharma Limited — Health Canada Inspection Findings

Health CanadaInspected 2025-01-15 4 findingsContamination controlStability and storageLaboratory and QC controlsDeviation, CAPA, and investigation

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

Findings

1Contamination control

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

2Stability and storage

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

3Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

4Deviation, CAPA, and investigation

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

About this record

Extracted automatically from the document of the Health Canada inspection on 2025-01-15. 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

2025-06-19 · US FDA · 6 findings2025-01-15 · Health Canada · 11 findings2025-01-15 · Health Canada · 5 findings2025-01-15 · Health Canada · 6 findings2025-01-15 · Health Canada · 8 findings2023-10-18 · US FDA · 8 findings
Natco Pharma Limited company profile — full history Health Canada documents, 2025 Go to Findings search