Axxelent Pharma Science Private Limited — Health Canada Inspection Findings

The written specifications were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The temperature and/or humidity control was inadequate.

The company did not test the effectiveness of antimicrobial preservatives for a drug before it was marketed and/or at the end of its proposed shelf life.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The design, equipment, and/or maintenance of the testing laboratory was inadequate.

Printed packaging materials were not stored in an area with restricted access.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.