Inspection Record

Fratum Pharma Inc. (Division of Euro-Pharm International Canada Inc.) — Health Canada Inspection Findings

Health CanadaInspected 2026-03-09 3 findingsOther quality systemCleaning validationLaboratory and QC controls

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

Findings

1Other quality system

Critical production processes were not validated.

2Cleaning validation

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

3Laboratory and QC controls

The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

About this record

Extracted automatically from the document of the Health Canada inspection on 2026-03-09. 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

2022-08-30 · Health Canada · 8 findings
Fratum Pharma Inc. (Division of Euro-Pharm International Canada Inc.) company profile — full history Health Canada documents, 2026 Go to Findings search