A chain of private plasma clinics cleared ineligible donors at risk for a highly dangerous disease, operated dangerously over capacity and left one centre running without a physician substitute on site, according to a Health Canada report.

Blood safety advocates are calling for the federal agency to crack down on Grifols, after an inspection found multiple issues with donor screening and staff supervision, according to a Health Canada inspection report recently released under access to information law.

Grifols said in an emailed statement it’s addressing these issues and they never posed safety risks.

This comes after two people died in Winnipeg in October 2025 and January 2026 after donating plasma at different Grifols locations in the city.

“At a certain point, there is a requirement for Health Canada to do something more,” personal injury lawyer Gary Will said during an Ontario Health Coalition press conference Monday. 

“They have the power to suspend the licence. They have the power to charge Grifols, and they haven’t done that yet.”

A total of 25 serious adverse reactions, such as cardiac arrest and pulmonary embolism, have been reported since 2018 by centres currently operated by Grifols, according to Health Canada.

Will said his firm is exploring legal options for people impacted. He believes there are likely more injured donors. 

“We’re at risk of potentially ending up in another tainted blood crisis if we don’t address these shortcomings,” said Sara Labelle, a medical laboratory technologist who co-chairs the Ontario Health Coalition’s blood Safety committee, referring to the infection of thousands of Canadians with HIV or hepatitis C from poorly screened blood products in the 1980s.

Deemed eligible despite disease risk: report

Grifols incorrectly deemed multiple banned donors at risk of Creutzfeld-Jakob disease as eligible, “which could compromise the safety of the blood,” according to Health Canada’s March 30 report, which detailed the regulator’s inspection of Grifols’s head office in Oakville, Ont.

Two people were barred from donating due to risks related to a rare subtype of Creutzfeld-Jakob that comes from eating beef infected with bovine spongiform encephalopathy, or “mad cow disease.” That variant can be transmitted through blood. 

The two were initially deferred, but those deferrals were lifted, even though both donors “continued to meet the exclusion criteria requiring an indefinite deferral,” the report said. 

On May 23, 2025, Grifols also lifted multiple deferrals for donors who should have been excluded for a family history of Creutzfeld-Jakob, according to Health Canada’s inspection report. 

While Grifols reinstated a deferral that was incorrectly lifted on one ineligible donor, no investigation was conducted, and the list of other deferred donors wasn’t checked, the report says.

As a result, multiple other ineligible donors had their Creutzfeld-Jakob-related deferrals lifted on May 28, 2025, it says.

“The incomplete investigation did not adequately mitigate the risk and ensure the safety of the blood,” the report says. It does not say whether any plasma was collected from these donors. 

Health Canada did not respond to a request for comment by the deadline. It also did not respond to questions about an inspection of Grifols Etobicoke, Ont., location, completed June 4.

That inspection noted multiple deficiencies in donor screening, staff training and accident investigation, Health Canada’s website says.

CBC requested the full inspection report but had not received a response prior to publication. 

Capacity, supervision concerns: report

The report also detailed centres operating over capacity. 

On Jan. 3, 2025, a Health Canada inspection noted 119 donors, including new applicants, presented for donation at one of Grifols’s two Winnipeg centres, “while only one physician substitute was available on site.”

The report doesn’t specify which of the two Winnipeg locations it’s referring to.

Information provided during the inspection indicated the daily maximum capacity is 100 donors per physician substitute per day, the report says.

It also noted “a qualified physician substitute was not always on the premises while donor eligibility assessments” and other procedures were done.

The following day, the same centre collected plasma and assessed donors’ eligibility without any physician substitute on site, the report said.

In an emailed statement, a Grifols spokesperson said the company is immediately addressing the issues Health Canada identified, but maintained they never posed a risk to donor or patient safety. 

Grifols changed its Creutzfeld-Jakob exclusion criteria in March 2025 after receiving approval from Health Canada and lifted deferrals from some previously excluded donors as a result, the spokesperson said.

“There were no plasma units collected from donors” who met the exclusion criteria, according to the statement.

Of the donors whose deferral for the Creutzfeld-Jakob variant was lifted after the change, only two “were later identified as continuing to meet separate … exclusion criteria requiring ongoing deferral,” according to the spokesperson. Neither donated plasma during the period when the deferral was lifted, they said.

Stringent screening for disease: expert

Screening for Creutzfeld-Jakob is stringent because of how highly feared the always-fatal disease is, said Dr. Valerie Sim, an associate professor at the University of Alberta with expertise in prion diseases like Creutzfeld-Jakob.

“It’s like Alzheimer’s disease on steroids, if you will. It’s a disease that on average takes a person who’s completely healthy to bed-bound and dying within four months,” said Sim. 

While Health Canada’s reports raise questions about Grifols’s screening protocols, Sim said it’s highly unlikely that Creutzfeld-Jakob has contaminated the blood supply.

There are no records of the two most common types of the disease ever being transmitted by blood, she said. People with a family history are barred from donating out of an abundance of caution, even though there’s no evidence their blood could transmit the disease, said Sim.

Only the rare variant from “mad cow disease” exposure is known as being blood transmissible, but Sim said there haven’t been any cases of that variant anywhere in the world since 2016.

People with that variant usually decline quickly, and it’s unlikely a symptomatic person would even make it to a donation centre, said Sim.

“In terms of prion disease risk and exposure, that should be the least of anyone’s concerns in this particular situation,” she said. “There are a lot of other things I would be more worried about in blood exposure that isn’t thoroughly screened.”