OmniaBio Inc. — Health Canada Inspection Findings

The validation of aseptic processing was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate. The operators'aseptic practices were inadequate to maintain sterility.

The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

The sampling plan for raw materials was inadequate. A sample from each lot of raw materials was not fully tested against the specifications.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products. The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.

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