Firm Record
Isologic Innovative Radiopharmaceuticals Ltd. findings history
63 findings from 9 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Equipment and facilityOther quality systemDeviation, CAPA, and investigationLaboratory and QC controlsStability and storageComputer system validationAseptic processing and sterility assuranceComplaint and recall handlingContamination controlMaterial and supplier controlValidation and qualificationCleaning validationQuality unit oversight
Published inspection documents
2026-03-02
Health Canada
4 findingsMaterial and supplier control · Other quality system · Equipment and facility · Laboratory and QC controls The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
2025-08-20
Health Canada
8 findingsLaboratory and QC controls · Equipment and facility · Other quality system · Cleaning validation · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance The establishment of specifications was inadequate for packaging materials approved by the quality control department.
2025-07-15
Health Canada
6 findingsDeviation, CAPA, and investigation · Computer system validation · Equipment and facility · Other quality system · Contamination control Investigations into deviations, reports, and/or follow-up actions were inadequate.
2023-10-31
Health Canada
3 findingsStability and storage · Laboratory and QC controls · Equipment and facility The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
2023-06-20
Health Canada
6 findingsEquipment and facility · Stability and storage · Other quality system · Computer system validation · Deviation, CAPA, and investigation The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
2023-02-06
Health Canada
10 findingsAseptic processing and sterility assurance · Computer system validation · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Quality unit oversight · Other quality system The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not monitor the aseptic filling area frequently enough to avoid possible contamination or system deterioration.
2021-08-03
Health Canada
7 findingsOther quality system · Equipment and facility · Contamination control · Laboratory and QC controls · Deviation, CAPA, and investigation · Computer system validation The evidence required to demonstrate compliance with finished product specifications was inadequate.
2021-05-25
Health Canada
7 findingsDeviation, CAPA, and investigation · Stability and storage · Equipment and facility · Aseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2021-03-01
Health Canada
12 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Validation and qualification · Deviation, CAPA, and investigation · Complaint and recall handling · Stability and storage · Laboratory and QC controls The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator 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.
