Grifols is the only major commercial collector of plasma in Canada and has 17 sites across the country.Shannon VanRaes/The Globe and Mail
Health Canada flagged multiple deficiencies at a Grifols plasma collection centre in Winnipeg after a donor died, including concerns about how staff responded to alarms from donation machines, according to a report written by a federal inspector.
The document, which was obtained by The Globe and Mail and includes some redactions for privacy, is dated Dec. 22, 2025, and suggests Health Canada has pointed out some of the same concerns repeatedly with Grifols since 2022 without resolution.
Even after a second death in Winnipeg in January, Health Canada did not make public any concerns with the company’s operations until after media reports revealed the deaths in March, raising questions about why the regulator did not act or share its findings sooner.
Health Canada imposed terms and conditions on Grifols’s licences on April 1 because of “recurring, systemic deficiencies across several sites,” although the regulator said later it identified “no linkage” between the donors’ deaths and the donation process itself.
Grifols is the only major commercial collector of plasma in Canada, with 17 sites across the country. Plasma is a protein-rich fluid found in blood that is collected and processed into medicine.
Grifols operates in Canada as part of a partnership signed in 2022 with Canadian Blood Services, which has run almost all the blood and plasma donations in Canada for nearly 30 years. Barcelona-headquartered Grifols pays donors, while CBS does not. A government-funded charity, CBS spends $1-billion annually on plasma-derived medicines.
The document obtained by The Globe was prompted by the death of University of Winnipeg student Rodiyat Alabede. Ms. Alabede died after a plasma donation at a Grifols site on Taylor Avenue on Oct. 25, 2025.
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Nearly a month after the death, Health Canada personnel began a process called “compliance verification,” which included an on-site visit, interviews with staff and a review of documents. The regulator sent an interim letter outlining concerns on Dec. 5, followed by a more complete report on Dec. 22.
The document lays out five categories of deficiencies, including an insufficient analysis by the company of Ms. Alabede’s death; concerns about staff training; standard operating procedures being incomplete or not followed by staff; incomplete or illegible records; and ineffective actions taken by Grifols in response to past inspections.
Health Canada says multiple times in the report that Grifols staff did not always know or follow operating procedures when donation machines had alerts or alarms. For example, a user manual for the machines says to stop the collection process if an alert sounds that the pressure in a donor’s vein is too high during fluid return. In one incident (redactions make it unclear whether the donor being referred to is Ms. Alabede), an alarm indicated that a donor’s pressure was too high and staff resumed collections anyway.
Donation hall “staff were not adequately trained and knowledgeable in handling and/or documentation of all alerts/alarms and the subsequent actions to take for the Aurora machine during collection,” the letter said, referring to the brand name of the machine that withdraws plasma from a donor.
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Fourteen out of the 20 staff working in the donation hall where plasma is collected had been hired since February, 2025, the Dec. 22 letter notes.
It said staff were allowed to fail and retake a training quiz four times before follow-up actions were taken, and the content and order of questions did not change during each attempt.
The document also notes that tubing was set up incorrectly on at least one donation machine (whether this was one machine or all of them is unclear) and that staff did not consistently scan their operator badges when taking actions on the machines, as they are supposed to.
Grifols’s standard operating procedures also instructed staff to notify their “supervisor/manager” when certain scenarios occurred. However, Health Canada said there were no supervisors working in the donation hall during the visit. Grifols told Health Canada that some recently opened sites did not have supervisors, and there was no manager position in the company’s organizational structure.
Health Canada had previously done a compliance visit at the same site on Aug. 3, 2023, the letter said, after a donor experienced hemolysis, which refers to the destruction of red blood cells.
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The letter does not name the donor, but a Winnipeg resident has sued Grifols over a donation on July 15, 2023, that allegedly caused an “acute kidney injury” from the reinsertion of broken red blood cells. (In a statement of defence, Grifols said any injury was not its fault and that the donor was aware of the risks of the procedure. A judge has not yet heard the case.)
The 2025 review said the steps Grifols had said it would take after the 2023 incident were incomplete or not followed, such as not properly assessing the colour of the plasma after a donation. (Plasma is generally supposed to be a golden colour, but can have a different shade if broken red blood cells are present.)
Grifols did not respond to questions specific to the Winnipeg compliance verification, but acknowledged all of its centres are under Health Canada oversight.
“Following recent inspections, we submitted detailed action plans to Health Canada and began implementation immediately, with a focus on preventing recurrence and strengthening compliance across all centres,” the company said in an unsigned statement.
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Mark Johnson, a spokesperson for Health Canada, said the department was currently reviewing the corrective action plans proposed by Grifols and would take further action if necessary.
When asked if Health Canada had ever imposed restrictions or penalties on Grifols, Mr. Johnson said a centre in Saint John was found non-compliant in October, 2022, and could not open until a reinspection in June, 2023, resulted in a compliant rating.
He also pointed to a Grifols centre in Calgary that was found non-compliant in December, 2025, and a Regina location that was found non-compliant in January. However, both of those locations continue to operate despite their licence rating.
Jason MacLean, chair of the Canadian Health Coalition, an advocacy group for public health care, said the review shows a systemic issue with both deficiencies at the sites and Health Canada’s oversight, as well as the need for Health Canada to act more quickly.
“I believe that people should be held accountable,” he said.