1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Eugia Pharma Specialities Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
3Equipment and facility
The maintenance of the premises was inadequate.
4Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
5Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
6Other quality system
The company's visual inspection of filled containers was inadequate.
7Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
8Stability 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.
9Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
10Material and supplier control
Precautions were not taken to ensure that containers were free from contamination by foreign material.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-10-21. 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.
