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Health Canada has slapped new terms and conditions on all of a company’s paid plasma centres after multiple failed inspections where the regulator found “recurring, systemic deficiencies.”
This comes after two people died in Winnipeg less than four months apart after giving their plasma at different Grifols locations in the city.
It also comes after the company’s Canadian head office in Oakville, Ont., failed its January inspection. The head office doesn’t collect plasma, but the federal health regulator said it oversees all 16 Canadian collection sites.
On Wednesday, a Health Canada spokesperson said they conducted a virtual inspection of the head office. The inspection found Grifols wasn’t accurately assessing a donor’s suitability, did not thoroughly investigate errors and accidents, and didn’t have enough properly trained staff members.
The inspection also found operating procedures were not always followed and that Grifols was allowing people to give plasma even when information shows “the safety of blood could be affected.”
Grifols, a Spanish-based company that specializes in producing plasma medicines, has more than a dozen centres in Canada to collect plasma, a protein-rich liquid that helps treat bleeding disorders, liver diseases and cancer. It’s also used to make a number of medications, such as immunoglobulin.
Health Canada’s new conditions apply to all 16 Grifols collection centres in Canada, and involve:
- Reducing the number of appointments so staff can fully follow procedures.
- Reassessing the number of fully trained personnel required for positions.
- Ensuring the quality assurance department reviews completed and documented donor suitability records.
- Reviewing donor files before updating donor eligibility.
- Implementing additional oversight for newer staff.
- Conducting an internal annual audit of all regulated activities, ensuring any deficiencies identified are documented and investigated, and submitting the audit to Health Canada.
Grifols did not immediately respond to a request for comment.
A spokesperson for Health Canada said the conditions will remain in place until Grifols shows “sustained compliance” with blood regulations at all licensed sites.
The spokesperson said it “identified quality management issues” during the head office inspection, which began Jan. 28.
“Health Canada had prioritized an inspection of the Grifols head office to review its quality management system at a national level since the department had identified quality management system observations at multiple Grifols sites during routine inspections,” the spokesperson said in an emailed statement Wednesday.
The spokesperson said Health Canada has required “corrective actions” from Grifols and “will continue to closely monitor progress” of their implementation.
The identified issues are not “considered critical,” the spokesperson wrote.
Changes come too late: advocate
One Winnipeg doctor is encouraged by Health Canada’s actions, saying the new conditions show the system is working.
“Deficiencies were found, gaps were filled and … [corrective] actions taken. So I think that’s good news for donors in general,” Dr. Ryan Zarychanski, a hematologist who specializes in blood disorders, said Thursday.
Plasma collection is safe, Zarychanski said, and it will be important to learn the outcome of Health Canada’s investigation into the two Manitoba deaths.
“Getting to the bottom of what happened in Winnipeg, which … appears to be ongoing, is an important step,” he said.
But the provincial director of the Manitoba Health Coalition, a non-profit health-care advocacy group, said these new terms should have been in place already.
“These conditions are coming too late,” said Noah Schulz, who wants paid plasma banned in Canada.
He says more investment is needed in the voluntary public system run by Canadian Blood Services. People can donate plasma at its William Avenue location in Winnipeg, but are not financially compensated.
Except in Quebec, where it’s run by Héma-Québec, Canada’s blood supply is managed by Canadian Blood Services, which entered into an agreement with Grifols in 2022 to help collect plasma on its behalf.
“We need to have national campaigns focusing on boosting our blood and plasma supply in Canada,” Schulz said. “We can do these things successfully if there is that political will.”
There is a shortage of plasma across the country, and Canadian Blood Services officials say demand for immunoglobulins is on the rise.
No link found between deaths, plasma collection
The two Winnipeg deaths are still under review by Health Canada, which confirmed it received two reports of fatal adverse reactions in plasma donors — one in October 2025 and another on Jan. 30, 2026.
One of those people was 22-year-old Rodiyat Alabede. The international student from Nigeria died on Oct. 25 after friends say she gave plasma at the Grifols location on Taylor Avenue.
Little is known about the second person, whose death was reported as a fatal reaction after a donation at the Grifols location on Innovation Drive.
Health Canada says no link has been found between the deaths and plasma collection.
Two other recent Grifols inspections resulted in non-compliant ratings in Calgary and Regina.
