PF Consumer Healthcare Canada ULC — Health Canada Inspection Findings

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

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

Yields and/or the reconciled quantities were not checked at appropriate stages. Evaluation of production processes, equipment, and/or materials was inadequate. Line clearance was not performed before starting new processing operations.

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

The annual product quality review procedure was inadequate.

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.

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