1Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
Inspection Record
Juno Pharma Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
The qualification and/or verification of utilities and/or support systems 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 company did not adequately protect sterilized material to prevent re-contamination after sterilization.
6Equipment and facility
The written clothing standards for each environmental grade were inadequate. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
9Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-24. 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.
