Lawson Health Research Institute — Health Canada Inspection Findings

A reduced retesting program for raw materials was in place without the raw material vendor certification. The standard operating procedures or records for shipping and receiving raw materials were inadequate.

The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.

The annual product quality review procedure was inadequate.

The usage logs for the equipment used for significant processing and/or testing operations were inadequate.

The implementation of a self-inspection program was inadequate.

The master formulas to control the manufacturing process were inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.