Open this photo in gallery:
Grifols’s plasma collection sites, such as its centre in Regina, have been closed to donors since Aug. 14, after a series of critical inspections from Health Canada and public scrutiny following the deaths of two donors in Winnipeg.Danielle Tocker/The Globe and Mail
A Health Canada inspection of a facility in Regina run by Grifols, the country’s only major private collector of blood plasma, found multiple plasma donors with punctures and bruising on their arms who were allowed to donate without proper medical assessments, newly obtained documents show.
The inspection report also found a donor who had disclosed to Grifols that they had sexual contact with someone who had HIV/AIDS was inappropriately allowed to donate twice.
These details, which have not been previously published, explain why Health Canada found the clinic to be “non-compliant” with federal regulations in February, although the regulator allowed the centre to keep operating.
Graham Sher, the chief executive officer of Canadian Blood Services, which has a partnership with Grifols and distributes the company’s plasma-derived products, said the safety of medicines made from the plasma of Grifols’ donors has never been compromised.
Grifols temporarily closed all of its collection centres in Canada as of Aug. 14, after a series of critical inspections from Health Canada and public scrutiny following the deaths of two donors in Winnipeg. The company said it is using the temporary closure to retrain staff and work with Health Canada and CBS to improve its operations. It has not announced a reopening date.
Spanish parent company of Grifols takes full ownership of Canadian operations
Plasma is a golden-coloured fluid found in blood that is used to make medicine, particularly for patients with immune deficiencies.
Grifols, a Barcelona-headquartered company, operates in Canada as part of an agreement signed in 2022 with Canadian Blood Services, the national charity that manages the country’s blood supply. CBS relies on volunteers for blood and plasma donations, while Grifols pays donors. CBS spends more than $1-billion per year on supplying hospitals with drugs made from plasma and other related products.
Health Canada’s inspection of the Regina location, which ran from Jan. 13 to 23, found a series of deficiencies, including with how the facility screened donors and followed operating procedures.
The report, dated Feb. 20 and obtained by The Globe and Mail, found that “multiple donors presenting with punctures and bruising near the venipuncture site were permitted to proceed with donation without documented additional assessment.” The report does not specify how many donors this observation applied to.
It cites an example of a donor on Jan. 13 who “presented with bruising and puncture marks on both arms” and was deemed eligible for donation by a Grifols staff member without an assessment by someone acting under the supervision of a physician. (That role, referred to as a “physician substitute” in federal regulations, is often performed by a nurse at Grifols collection centres.)
Grifols said in a response filed with Health Canada on March 20 that there is “no established guidance for what constitutes an acceptable forearm check by donor screeners to differentiate markings that result from frequent donations compared to high-risk activities or injury.” The company said it would update its screening procedures with examples of “acceptable versus unacceptable forearm checks.”
A high-risk activity that could lead to forearm bruising and puncture marks is intravenous drug use. CBS’s website says those who have injected drugs must wait 12 months from the date of last use before donating blood to the charity.
What we know so far about Grifols’s plasma pause and Health Canada’s safety concerns
Health Canada inspectors also wrote that a donor in November, 2025, was permitted to donate twice despite answering “yes” to the question of whether they had “ever had sexual contact with anyone who has ever had HIV/AIDS or has ever had a positive test for HIV/AIDS virus.” The report says such a response should cause someone to be barred from donating. However, a staff member at Grifols, who was a “physician substitute in training,” changed the response to “no,” allowing the person to donate.
Grifols said in its response to Health Canada that the error was discovered on the donor’s third visit. The company told Health Canada it then “rejected” the plasma collected during the prior two visits and applied an indefinite ban on the donor. The Grifols report said that staff member was no longer employed by the company.
Other observations from the inspection of the Regina centre included a person donating twice within 48 hours even though donations are supposed to be more than two days apart, and the process for verifying donors’ addresses as being “ineffective.”
Health Canada inspections of other Grifols locations have raised concerns about staff failing to properly respond to alarms on donation machines and physicians (or physician substitutes) not always being present.
Grifols told The Globe Tuesday that the safety of plasma and plasma-derived medicines is the company’s number-one priority. “At no point donor safety or the quality and safety of plasma collected at our Regina centre – or at any of our other Canadian centres – has been compromised,” Grifols said in an unsigned statement.
It said collected plasma goes through rigorous tests to detect infectious agents, including syphilis, hepatitis B and C and HIV.
The company said that, since January, 2026, no donors at its Canadian centres have tested positive for HIV or hepatitis B virus, though two donors were confirmed positive for hepatitis C virus and two had indeterminate results. Grifols said that in 2025, one donor was confirmed positive for HIV, one for hepatitis B and two for hepatitis C.
Grifols revises reports of serious injuries or death at its centres down to six from 25 since 2018
“Overall, the number of confirmed positive donors remains very low and well below Grifols Canada’s established epidemiological alert limits,” the company said.
Strict screening of blood and plasma donors for diseases is an important part of managing health and safety. In the 1980s, tens of thousands of Canadians contracted hepatitis and HIV in a tragedy that came to be known as the tainted blood scandal. Afterwards, an exhaustive commission overseen by Justice Horace Krever into the crisis led to an overhaul of Canada’s blood system and the creation of Canadian Blood Services.
Dr. Sher said in an interview Tuesday that advances in manufacturing processes and testing have meant no cases of HIV, hepatitis B or hepatitis C have been transmitted through blood products since the organization’s founding.
He said he could not address specific findings of Health Canada’s report on the Regina centre. He said inspections are point-in-time observations and that a focus on specific findings ignores the wider context of the safety of products made from human plasma.
“I’m not disputing that there have been a set of systemic findings across many of the Grifols sites,” Dr. Sher said.
But he said he believes the company will use its current collection pause to improve its entire operations.
“I am assured and I am confident that Grifols is taking this very seriously,” he said.