1Computer system validation
The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Catalent Ontario Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Laboratory and QC controls
The quality control department did not record, report, and/or investigate damage to the containers or any other problems that might adversely affect the quality of materials. The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
5Other quality system
The recorded information or details were inadequate.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Laboratory and QC controls
The quality control department did not release the materials that were used.
8Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-16. 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.
