Eagle Analytical Services Canada, Corp. — 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 creation, maintenance, processing, and/or review of laboratory data was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.