Optimi Labs Inc. — Health Canada Inspection Findings

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

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

The recorded information or details were inadequate. The procedures to identify the contents of each container were inadequate.

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

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

Validation studies were not conducted in keeping with the predefined protocols.