Firm Record

Patheon Inc. findings history

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

Health Canada 2021-01-18 ~ 2025-10-14 5 documents 34 findings

Areas cited

Computer system validationOther quality systemEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationCleaning validationContamination controlMaterial and supplier controlTraining and personnelRegulatory reporting and change controlDocumentation and recordsComplaint and recall handlingStability and storage

Published inspection documents

2025-10-14 Health Canada 6 findingsEquipment and facility · Material and supplier control · Computer system validation · Laboratory and QC controls · Contamination control The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. 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. 2024-07-10 Health Canada 3 findingsComputer system validation · Other quality system · Complaint and recall handling The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. 2024-01-08 Health Canada 10 findingsDeviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Material and supplier control · Computer system validation · Equipment and facility · Cleaning validation · Training and personnel 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. 2022-09-21 Health Canada 11 findingsStability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation · Cleaning validation · Equipment and facility · Documentation and records · Regulatory reporting and change control · Other quality system The temperature and/or humidity control was inadequate. 2021-01-18 Health Canada 4 findingsContamination control · Deviation, CAPA, and investigation · Computer system validation The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

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 Patheon Inc. — including inspection classifications Browse by document Go to Findings search