Investigative Science Incorporated — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The training of personnel before new or revised standard operating procedures were implemented was inadequate.

The maintenance of records was inadequate.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

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

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The validation and/or the documentation of test methods was inadequate.