Catalent CTS, LLC — 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 availability, implementation, and/or quality of the written sanitation program was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. 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 availability or the content of the authentic certificate of analysis was inadequate.

The assessment to release finished products was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate.

The written protocol and/or the assessment of the test method transfer was inadequate. The validation and/or the documentation of test methods was inadequate.

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

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

Reworked or reprocessed drug lots were not included in the ongoing stability program.