Inspection Record

Mantra Pharma Inc. — Health Canada Inspection Findings

Health CanadaInspected 2023-05-10 4 findingsLaboratory and QC controlsOther quality systemStability and storageDeviation, CAPA, and investigation

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

Findings

1Laboratory and QC controls

The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.

2Other quality system

Identifying and/or investigating the failures to meet finished product testing requirements was inadequate.

3Stability and storage

The temperature and/or humidity control was inadequate.

4Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-05-10. 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

2021-12-07 · Health Canada · 6 findings
Mantra Pharma Inc. findings history — including this company's other documents Health Canada documents, 2023 Go to Findings search