Health Canada inspections of collection centre also found training issues and failures to apply corrective measures, leading to non-compliance ruling

A Calgary for-profit blood plasma collection clinic violated multiple safety regulations including accepting ineligible donors, mislabelling donation bottles and failing to do preventative maintenance.

Health Canada inspections of the Grifols plasma centre in northeast Calgary in December 2025 also found its operators continued using malfunctioning equipment and didn’t investigate or address accidents and errors.

The details of the violations are contained in an inspection document dated January 2026, obtained by Postmedia. The federal health agency’s ruling of non-compliance preceded Spain-based Grifols, Canada’s largest private plasma collector, temporarily shutting down its 16 collection operations across Canada last month.

That move followed the deaths of two people in 2025 and 2026 after donating plasma in the company’s clinics, with both collections occurring at its Winnipeg locations. One of those was Rodiyat Alabede, a 22-year-old international student who died of cardiac arrest on Oct. 25 of last year.

According to Health Canada’s inspection notice, Grifols’ Calgary plasma centre allowed one person to donate 16 times between March 2023 and June 2025 and whose plasma was later distributed, although the clinic “was unable to determine whether the donor met eligibility requirements for donations made during this period.”

In another instance, the federal regulator said the clinic couldn’t prove it accepted a donation from a person following a proper interim period after the donor had reported having a lung infection.

“The establishment applied an incorrect deferral timeframe for a donor with a reported systemic infection, leading to a possible incorrect assessment of donor eligibility at their next donation,” said Health Canada.

It went on to say the clinic failed to take corrective measures regarding ineligible donors “to prevent recurrence.”

And it concluded the staff training at the Sunridge Way N.E. plasma donation site was insufficient.

“These physician substitutes were involved in multiple deviations that resulted in incorrect donor eligibility assessments, indicating that proper training was not maintained while performing activities,” states the nine-page report that found 10 areas of non-compliance.

The inspections also found incomplete, inaccurate, illegible and not easily accessible records used to ensure quality controls and expiry dates were followed.

Plasma is a key ingredient in some medications known as immunoglobulin products, which are used for immunodeficiency, autoimmune and neurological disorders. There are shortages in the global supply chain even though it can be donated more frequently than whole blood.

Health Canada also found Grifols to be non-compliant in other locations in the country but never ordered their closure, a move taken by Grifols to which the federal regulator voiced approval. There’s been no time given for the clinics’ possible reopening.

The advocate for Alabede and her family said it’s outrageous Health Canada hasn’t moved to suspend Grifols’ licence and order an external investigation into the woman’s death.

“We can’t trust Health Canada right now, they have a duty and an obligation to suspend (Grifols’) licence to have an external audit,” said Kat Lanteigne, former executive director of BloodWatch.org, a group that grew out of tainted blood scandal in the 1980s and 1990s, and advocates for a public, voluntary blood supply.

“Health Canada is an enabler of Grifols.”

She called the findings from the Calgary inspections “shocking” and that a Health Canada non-compliance notification is extremely damning.

“You don’t get a non-compliance rating unless you’ve broken the law and it’s very hard to get that rating,” said Lanteigne.

“What this company has done is introduce risk to the donor system and blood supply to very little benefit — and we subsidize them.”

In a statement last month, Grifols said it took voluntary closure action due to “unfounded attention that has been focused on compensated plasma collection.”

Lanteigne scoffed at that, saying the multiple non-compliance ratings “are facts” that can’t be denied and are “samples of a broader picture.”

The partnership between Grifols and Canadian Blood Services was a topic of controversy when struck in September 2022, as it marked a private enterprise entering the field of blood collection. It came at a time when Canada’s plasma self-sufficiency was at just 15 per cent of its 50 per cent target.

Canadian Blood Services says the domestic supply of immunoglobulins has more than doubled since then, now reaching 34 per cent.

As for Alabede’s death last October, Health Canada said there was no link between donating plasma and the Winnipeg fatalities, a conclusion contested by Lanteigne and the woman’s family.

Lanteigne contends alerts meant to signal potential medical problems during the collection process were ignored while Alabede — who had a cardiac condition — was making her first plasma donation because she badly needed the money.

“It points to the danger of commercializing the donor, it’s how predatory it is,” she said. “It’s the model itself that’s problematic.”

But Grifols said it stands behind health authorities that have concluded its collection process played no role in the woman’s death.

“Health Canada and the Manitoba Medical Examiner each concluded that there was no link between the serious adverse event and the plasma donation process. Grifols accepts these findings and respects the authorities that conducted these reviews,” the company said in an email.

And Grifols contends none of the Health Canada findings indicate its operations posed a risk to public safety and that the areas of non-compliance identified by Health Canada have or are being dealt with, adding the federal agency has ended its inspection process of the Calgary clinic.

“We review regulatory feedback seriously and use it to drive ongoing improvements in training, staffing, oversight and centre operations that support a safe and positive donor experience,” they said.

The company didn’t give a date for reopening its clinics to the public but will do so “as soon as feasible in agreement with Health Canada.”

Health Canada said that last March, following its discovery of “recurring, systemic deficiencies” at several Grifols sites, terms and conditions were added to all of its licenses and will remain in place until the company shows consistent compliance.

Following a June inspection of its Winnipeg Taylor Ave. site, “Health Canada issued a letter to Grifols Head Office indicating that several conditions established by the Department were not satisfied,” Health Canada said in an email.

“In the letter, Health Canada warned that failure to address the identified deficiencies could result in further compliance and enforcement actions, including, but not limited to, the suspension of some operations.”

It’s not clear when the company will resume collections, said Health Canada, but once it does, they will be closely monitored and if compliance isn’t met, license suspension could occur.

It’s not within the ministry’s mandate to determine cause of death but that “Health Canada’s role with respect to donor safety pertains to safety as it relates to the safety of blood and plasma as regulated health products.” 

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