Firm Record

Catalent Ontario Limited findings history

35 findings from 5 inspection documents published by regulators. Each row below says what its date means.

Health Canada 2022-03-22 ~ 2025-08-18 5 documents 35 findings

Areas cited

Other quality systemEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationContamination controlComputer system validationValidation and qualificationCleaning validationStability and storageMaterial and supplier controlLabeling and packaging

Published inspection documents

2025-08-18 Health Canada 5 findingsContamination control · Computer system validation · Other quality system · Laboratory and QC controls · Equipment and facility The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. 2025-07-07 Health Canada 8 findingsOther quality system · Laboratory and QC controls · Contamination control · Deviation, CAPA, and investigation · Labeling and packaging · Stability and storage The handling of standard operating procedures for good manufacturing practices was inadequate. 2024-12-02 Health Canada 6 findingsEquipment and facility · Other quality system · Contamination control · Deviation, CAPA, and investigation Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified. The procedures to identify the contents of each container were inadequate. 2022-05-16 Health Canada 8 findingsComputer system validation · Cleaning validation · Equipment and facility · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. 2022-03-22 Health Canada 8 findingsMaterial and supplier control · Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Validation and qualification The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging. The temperature and/or humidity control was inadequate.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Catalent Ontario Limited — including inspection classifications Browse by document Go to Findings search