Atlas Pharma Inc. — Health Canada Inspection Findings

The system for reviewing, revising, and approving standard operating procedures was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

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

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

The effectiveness of the training was not assessed by the firm. The ongoing training of personnel was inadequate.

The quality control department did not undertake all of the required activities. The qualifications, the number of laboratory personnel, and/or the individual in charge was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.