|
Newsletter
|
Donate
Inspection of plasma giant Grifols’ head office found ‘deficiencies’: Health Canada
Posted: March 27, 2026
(March 26, 2026) By: Gabe Oatley, TorontoToday
The inspection of the Oakville facility identified ‘quality management’ and ‘processing’ deficiencies. It follows two recent deaths of plasma donors at the company’s clinics.
A recent Health Canada inspection of embattled pharmaceutical giant Grifols’ head office in Oakville, Ont. identified a number of deficiencies, including problems with how the company assesses the suitability of plasma donors and with the qualifications or training of its personnel.
The initial results of the inspection, posted recently to a Health Canada website, come as the Spanish pharmaceutical company faces increasing domestic scrutiny after two people recently died following blood plasma donations at the company’s clinics in Winnipeg.
Grifols, which operates 17 paid plasma collection clinics across Canada, including two in Toronto, has said that it has “no reason to believe that there is a correlation between the donors’ passing and plasma donation.”
However, some health advocates and politicians have disputed the company’s claim and renewed calls for the federal government to ban pay-for-plasma collection clinics nationwide following the deaths.
The deficiencies Health Canada identified at Grifols’ Canadian headquarters in Oakville are just the latest in a series of issues flagged by the federal health regulator at several of the company’s for-profit clinics since Grifols began operating in Canada in 2022.
Over the past three and a half years, four of the company’s clinics have been found out of compliance by Health Canada inspectors.
This is the same number of non-compliant inspection results as have been issued to all other facilities licensed to collect blood or plasma in Canada combined since 2012, according to the federal health regulator.
Most recently, Health Canada found a Grifols plasma facility in Regina out of compliance in January and its Calgary facility out of compliance in December.
In contrast, Canadian Blood Services, the operator of Canada’s blood collection and distribution system outside of Quebec, has never received a non-compliant inspection finding for any of its dozens of clinics nationwide, per Health Canada.
Natalie Mehra, executive director of advocacy organization Ontario Health Coalition, said the new details about the company’s inspection track record are shocking.
“I’m outraged,” she said in an interview with TorontoToday. “We can now see a clear pattern of repeated violations of standards by Grifols.”
Mehra, whose organization has advocated against the introduction of paid plasma collection centres for years, said Health Canada must move to shut the company’s clinics down.
“[This] should result now in the cancellation of their licences,” she charged.
TorontoToday asked Grifols for more information about the deficiencies Health Canada recently identified at its Oakville headquarters, but the company would not comment on an ongoing inspection. In a statement, it said “Health Canada’s robust inspection framework and associated regulations help us to ensure that we are operating within their guidance and in pursuit of continuous improvement.”
In response to earlier questions about its inspection track record relative to its peers, Grifols maintained “donor safety and plasma quality” are its top priorities.
In an emailed statement, a company spokesperson said it is working to “swiftly” address the deficiencies identified by Health Canada during the recent inspections of its Calgary and Regina clinics.
Following the two deaths in Winnipeg, TorontoToday endeavoured to reach Health Minister Marjorie Michel to inquire whether a ban on paid plasma clinics is being contemplated, but a spokesperson for the minister did not provide a response, redirecting questions to Health Canada.
Repeat concerns about donor suitability assessments
During the inspection of Grifols’ head office, Health Canada inspectors identified an unspecified deficiency with the company’s assessment of plasma donor suitability — an area of concern that was also flagged at the Regina and Calgary facilities just weeks earlier.
When TorontoToday visited Grifols’ two plasma donation sites in Toronto last year, several clients entering and exiting the clinic said they donated plasma frequently because they were struggling financially. The company uses social media advertising to draw clients, who are paid on a sliding scale and can receive bonuses the more often they donate.
For example, Grifols will pay a “bonus” of $100 if an individual gives blood plasma 100 times in a calendar year.
In an emailed statement to TorontoToday, Health Canada said the inspection of Grifols’ Regina site found that in at least one case, the company collected a donor’s plasma twice within 48 hours, a violation of its federal licence.
In Ontario, Grifols is acting as an “agent” of Canadian Blood Services (CBS), allowing the company to skirt the province’s ban on paid plasma collection. In 2019, Health Canada permitted the company to extract plasma at double the rate of the CBS.
While CBS is allowed to extract plasma from an individual once every six days, with a maximum of 52 times per year, Grifols is permitted to collect every two days (with a maximum of twice in a seven-day period), up to a maximum of 104 draws per year.
A recent meta study found that twice-weekly plasma collection can cause negative health impacts for donors, including impacting an individual’s levels of immunoglobulin, an infection-fighting antibody, and potentially leading to iron deficiency.
Concerns identified with respect to accident response
Separately, the non-compliant inspections at Grifols’ clinics in Regina and Calgary also found the company’s “validation, calibration, cleaning, or maintenance of critical equipment were not always sufficient,” and that the clinics “did not thoroughly investigate errors and accidents and determine corrective and preventive actions.”
The Oakville inspection also identified several deficiencies in the area of quality management.
The inspection, which began about three months after a 22-year-old international student died after donating plasma at one of the company’s Winnipeg clinics, found problems with Grifols’ operating procedures and “personnel qualifications or training,” as well as a failure to meet Health Canada’s “accident investigation and/or reporting requirements.”
Could more action be taken?
Mehra said Health Canada must answer for why it has not taken more proactive steps to ensure Grifols’ clinics are operating in compliance with federal rules.
“Why are there no consequences for Grifols for repeated non-compliance across the country?” she asked. “It appears they’ve been allowed to expand.”
After a finding of non-compliance, the federal health minister may choose to suspend all or part of an establishment’s licence.
Canada’s laws also mandate that the minister must cancel an operator’s licence to collect blood or blood components if “the establishment’s compliance history demonstrates an inability to consistently conduct its activities in accordance with” the regulations.
The minister has not taken any such steps with Grifols.
In an emailed statement, Health Canada said following non-compliant inspections at Grifols’ clinics in Saint John, NB, in 2022 and in Saskatoon, SK, in 2023, Health Canada conducted re-inspections about eight months later and confirmed the company’s planned corrective actions had been implemented.
Health Canada said the inspection process for non-compliant cases in Calgary and Regina are still ongoing.
As for the head office inspection, the federal regulator said it will “not hesitate to take action” should a finding of non-compliance be identified.
Grifols summoned to appear before federal committee
On Thursday afternoon, a Grifols executive is set to appear before the House of Commons’ Standing Committee on Health as part of its examination of Canada’s “pharmaceutical sovereignty.”
Grifols was invited by the committee to appear at a meeting earlier in March, but declined. The committee responded to the refusal by taking the rare step of summoning a Grifols executive — a legally binding order.
In an interview with TorontoToday on Wednesday, Conservative MP Matt Strauss, a medical doctor who sits on the health committee, said he believes there are many unanswered questions the company must address in wake of the deaths linked to its Winnipeg clinics.
Either something “astoundingly statistically improbable — or something quite medically incorrect has occurred,” he said of the deaths.
“This is simply unheard of, and constituents in my riding are just, in general, concerned about the practice of paying for any sort of blood plasma, or tissue donation,” he said.
An agenda for the meeting indicates the company’s vice-president of sales and commercial operations, Mary Hughes, is expected to appear before the committee.
Hughes may also be called upon to answer questions about reporting by the Globe and Mail that found Grifols has sold medicine to other countries that was made from Canadian-donated plasma — something Canadian Blood Services promised would not occur.
The report prompted several Conservative MPs to call for a parliamentary investigation of the Spanish drugmaker. Strauss said the committee did not decide to move forward with the probe, but that he and other committee members will ask questions on Thursday.
Editor’s note: This story has been updated with a response from Grifols that was not received until after publication.
