Delta Pharma Inc. — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The establishment and/or the maintenance of a data governance plan was inadequate.

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

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

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.

The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.