Isologic Innovative Radiopharmaceuticals Ltd. — Health Canada Inspection Findings

The establishment of specifications was inadequate for packaging materials approved by the quality control department.

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

The quality control department did not undertake all of the required activities.

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

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

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

The operators'aseptic practices were inadequate to maintain sterility. Warning systems did not alert personnel when air pressure fell below established limits. The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. Evaluation of production processes, equipment, and/or materials was inadequate. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.