1Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas.
Inspection Record
Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
3Aseptic processing and sterility assurance
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
4Other quality system
The recorded information or details were inadequate.
5Equipment 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.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-05-20. 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.
