Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) — Health Canada Inspection Findings

The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The validation and/or the documentation of test methods was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.

The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.

The written sanitation program for clean areas was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate.

The availability, implementation, and/or quality of the written sanitation program was inadequate.

The maintenance of the premises was inadequate.

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The company did not take precautions to minimize contamination during all processing prior to sterilization.