Bora Pharmaceutical Services Inc. — Health Canada Inspection Findings

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. 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 calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

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

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