Pantheon Cannabis Group Inc. — Health Canada Inspection Findings

Critical production processes were not validated. The master formula for packaged products did not include the required information. Packaging operations were not performed in keeping with the written operating procedures or specifications.

The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.

The quality control department did not undertake all of the required activities.

The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.

The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.

The availability, implementation, and/or quality of the written sanitation program was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.