Medreich Ltd. — Health Canada Inspection Findings

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 sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

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

The annual product quality review procedure was inadequate.

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