1Other quality system
The handling of standard operating procedures for good manufacturing practices 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
2Other quality system
The written hygiene program was inadequate.
3Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
4Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
5Deviation, CAPA, and investigation
The quality control department did not undertake all of the required activities. Investigations into deviations, reports, and/or follow-up actions were inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
7Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080). Measures to ensure the compliance of the contracted test laboratories were inadequate.
8Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-07. 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.
