Firm Record

Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) findings history

55 findings from 7 inspection documents published by regulators. Each row below says what its date means.

Health Canada 2021-12-07 ~ 2025-05-20 7 documents 55 findings

Areas cited

Equipment and facilityOther quality systemAseptic processing and sterility assuranceContamination controlDeviation, CAPA, and investigationComputer system validationRegulatory reporting and change controlLaboratory and QC controlsStability and storageTraining and personnelMaterial and supplier controlLabeling and packaging

Published inspection documents

2025-05-20 Health Canada 6 findingsAseptic processing and sterility assurance · Contamination control · Other quality system · Equipment and facility · Deviation, CAPA, and investigation The process was inadequate for the environmental classification of aseptic or clean areas. 2024-10-30 Health Canada 6 findingsAseptic processing and sterility assurance · Contamination control · Regulatory reporting and change control · Deviation, CAPA, and investigation · Computer system validation · Equipment and facility The company's investigations of microbial contamination in critical areas were inadequate. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. Evaluation of production processes, equipment, and/or materials was inadequate. The quality control department did not undertake all of the required activities. 2023-09-07 Health Canada 12 findingsAseptic processing and sterility assurance · Computer system validation · Contamination control · Other quality system · Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products. 2023-09-07 Health Canada 4 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · 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. 2021-12-07 Health Canada 5 findingsComputer system validation · Other quality system · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. 2021-12-07 Health Canada 14 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel · Equipment and facility · Stability and storage · Other quality system · Contamination control The operators'aseptic practices were inadequate to maintain sterility. 2021-12-07 Health Canada 8 findingsComputer system validation · Other quality system · Equipment and facility · Labeling and packaging · Contamination control The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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 Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) — including inspection classifications Browse by document Go to Findings search