Primera Analytical Solutions Corp. — Health Canada Inspection Findings

The ongoing stability program for a drug was inadequate.

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

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

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The preventative maintenance and repair of the equipment was inadequate.

The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

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

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.