United Therapeutics Corporation — Health Canada Inspection Findings

Investigations into deviations, reports, and/or follow-up actions were inadequate. Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.

The recorded information or details were inadequate.

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

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material. The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products.