1Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
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 operators'aseptic practices were inadequate to maintain sterility.
3Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
4Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
5Laboratory and QC controls
The sampling plan for packaging materials was inadequate. The establishment of specifications was inadequate for packaging materials approved by the quality control department.
6Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
7Other quality system
The company's visual inspection of filled containers was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-26. 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.
