Pharmascience Inc. — Health Canada Inspection Findings

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

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

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

Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

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 implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

The evidence required to demonstrate compliance with finished product specifications was inadequate.

The ongoing stability program for a drug was inadequate.

Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water. The labelling of outlets for liquids and/or gases was inadequate.

The annual product quality review procedure was inadequate.

The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The retention time for records was inadequate.