1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Catalent CTS, LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Cleaning validation
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.
4Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
5Other quality system
The assessment to release finished products was inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
7Laboratory and QC controls
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.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
10Stability and storage
Reworked or reprocessed drug lots were not included in the ongoing stability program.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
