1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
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
2Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
3Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.
4Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Other quality system
The company's visual inspection of filled containers was inadequate.
7Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
8Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-07. 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.
