Grifols, a major commercial blood-plasma collector in Canada, has stated that it did not collect plasma from donors flagged by Health Canada for potential Creutzfeldt-Jakob Disease (CJD) risk factors, despite regulatory concerns raised earlier this year. The company issued the clarification following a Health Canada inspection report dated March 30, which identified lapses in donor screening procedures related to CJD and its variant, linked to mad cow disease.

Health Canada’s inspection of Grifols’ head office in Oakville, Ontario, was initiated after reviewers found compliance issues at some plasma donation centers and after two donor deaths in Winnipeg over the past year. The report highlighted that several individuals who should have been excluded due to CJD risk factors were instead permitted to donate plasma. Grifols initially confirmed it was taking corrective actions but did not detail the status of plasma from these flagged donors.

In response to queries following the report’s public release, Grifols provided additional information stating that none of the individuals in question ultimately donated plasma. “No plasma was collected from donors with CJD risk factors that would have made them ineligible to donate, and no donor or patient was placed at risk,” the company said in an unsigned statement.

The inspection also raised concerns about operational aspects, including donation centers not consistently having physicians on site and exceeding donor capacities relative to staffing levels. These findings prompted Health Canada to impose licensing terms and conditions covering 16 of Grifols’ 17 Canadian locations, mandating increased staff supervision and limiting the number of donors present at any given time.

Health Canada further explained that part of the issues stemmed from evolving donor eligibility criteria regarding geographic risks associated with mad cow disease. Restrictions, historically barring donors who lived in the United Kingdom, Ireland, or France during the 1980s and 1990s, were reassessed after new evidence indicated a “virtually non-existent” CJD risk from these populations. Canadian Blood Services and Héma-Québec had previously been authorized to lift these geographic exclusions in 2023, and Grifols received approval in 2024 to remove such criteria except for donors with United Kingdom residency or travel history.

The report also noted that Grifols did not consistently exclude donors with a family history of CJD, a factor considered critical by the regulator. Health Canada stated it will require regular updates from Grifols and retains the authority to conduct follow-up inspections to ensure compliance with blood safety regulations and corrective measures.

Grifols operates Canada’s only major paid plasma donation program, collaborating with Canadian Blood Services, which does not compensate donors. Plasma collected is shipped to a manufacturing facility in North Carolina for the production of plasma-derived medicines, such as immunoglobulin, which are then distributed to Canadian hospitals. Canadian Blood Services spends over $1 billion annually on plasma-related therapies.

The company emphasized it has safeguards within its manufacturing processes to prevent the use of plasma units that do not meet safety criteria. Health Canada noted that inspection findings reflect observations at a specific point in time, affirming that no plasma from donors with CJD risk concerns was collected. The regulator had not responded to earlier media inquiries about the matter.