Patheon Inc. — Health Canada Inspection Findings

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

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

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

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

The maintenance of the premises was inadequate.

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

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate.

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