Firm Record
Isologic Innovative Radiopharmaceuticals of Ontario Limited findings history
91 findings from 13 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Other quality systemAseptic processing and sterility assuranceEquipment and facilityStability and storageDeviation, CAPA, and investigationComplaint and recall handlingContamination controlComputer system validationLabeling and packagingTraining and personnelRegulatory reporting and change controlValidation and qualificationLaboratory and QC controlsMaterial and supplier control
Published inspection documents
2026-03-17
Health Canada
6 findingsTraining and personnel · Other quality system · Equipment and facility · Aseptic processing and sterility assurance The health examinations of personnel (pre-employment and/or ongoing) were inadequate.
2025-09-08
Health Canada
9 findingsStability and storage · Other quality system · Material and supplier control · Deviation, CAPA, and investigation · Contamination control · Equipment and facility The ongoing stability program for a drug was inadequate.
2025-02-04
Health Canada
9 findingsContamination control · Other quality system · Aseptic processing and sterility assurance · Stability and storage · Labeling and packaging · Equipment and facility The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
2024-06-11
Health Canada
5 findingsContamination control · Equipment and facility · Validation and qualification · Regulatory reporting and change control · Other quality system The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
2024-04-23
Health Canada
7 findingsDeviation, CAPA, and investigation · Complaint and recall handling · Computer system validation · Aseptic processing and sterility assurance · Other quality system The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2023-09-19
Health Canada
3 findingsOther quality system · Equipment and facility The recorded information or details were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
2023-08-21
Health Canada
6 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
2023-02-20
Health Canada
9 findingsComplaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Computer system validation · Labeling and packaging · Equipment and facility · Aseptic processing and sterility assurance · Other quality system The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
2022-05-30
Health Canada
4 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Other quality system · Contamination control The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
2022-02-15
Health Canada
10 findingsStability and storage · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control · Computer system validation · Validation and qualification · Aseptic processing and sterility assurance The temperature and/or humidity control was inadequate.
2021-05-18
Health Canada
6 findingsOther quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Stability and storage The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
2021-03-08
Health Canada
9 findingsAseptic processing and sterility assurance · Labeling and packaging · Training and personnel · Stability and storage · Complaint and recall handling · Other quality system The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
2021-02-08
Health Canada
8 findingsOther quality system · Computer system validation · Material and supplier control · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Stability and storage The recorded information or details were 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.
