Winnipeg facility that produces cancer-screening material passes inspection after repeated failures

The Winnipeg Cyclotron Facility in Manitoba, which is responsible for producing crucial materials used in cancer detection, recently received a passing grade on its latest Health Canada inspection. This comes after failing its two most recent reviews by the regulator, citing concerns such as mishandling test results, inadequate training of workers, and not following proper sterility practices.

CBC News reported earlier this year that the Winnipeg Cyclotron Facility, the only producer of medical isotopes in Manitoba, had been found non-compliant by Health Canada during its last two routine inspections. The most recent failure marked the fifth time in the past decade that the facility had been found non-compliant during an inspection.

The isotopes produced by the facility are used to create radioactive tracers injected into patients during PET scans. These tracers help highlight possible tumors in a scan, aiding doctors in determining the location and spread of cancer, as well as the effectiveness of treatment.

Experts expressed concerns that Health Canada could revoke the facility’s drug establishment license due to its repeated non-compliance findings. In 2018, the facility faced the threat of license suspension after failing its inspection. However, the Winnipeg Cyclotron Facility was able to demonstrate sufficient progress on corrective actions to maintain its license.

Routine inspections are conducted every few years to ensure that the facility meets Health Canada’s standards. Losing its license could result in a decrease in the number of scans performed in Manitoba, as the materials used have a short lifespan.

Following the latest inspection results, the facility has made significant changes to comply with Health Canada’s standards. This includes restructuring its quality unit, revising aseptic processes, and appointing a project manager to oversee a corrective action plan. Additionally, a lead radiochemist has been hired to ensure production processes meet expectations.

While the facility passed its most recent inspection, Health Canada made several observations that the staff will continue to address in the coming year. The facility, which opened in 2010, had previously failed inspections in 2020 and 2013, citing deficiencies in disinfection, documentation, and testing procedures.

Overall, the Winnipeg Cyclotron Facility has made significant improvements to address Health Canada’s concerns and maintain compliance with regulatory standards. The facility plays a crucial role in cancer detection in Manitoba and continues to work towards providing high-quality medical isotopes for PET scans.