Calgary for-profit plasma clinic rated ‘non-compliant’ during Health Canada inspection
A Calgary center that pays people for their plasma was designated as “non-compliant” by Health Canada in December for violating rules regulating the country’s blood supply, and the revelation is raising new questions about the safety of the industry.
Grifols, the private company that runs the facility, told CBC News it is working “expeditiously” to address the concerns.
It is in headlines after recent news two people died in manitoba After donating plasma at their Winnipeg collection centres.
Health Canada, which is reviewing the deaths, said no link was found between the donation process and the deaths. According to the agency, Three deaths have been recorded in the country after plasma donation. In the last 10 years.
Plasma contains key proteins and, when separated from the blood, the liquid can be used to make medicines for immune deficiencies, autoimmune diseases and other conditions.
Federal inspection reports show problems have been documented at several of Grifol’s Canadian plasma collection locations, including in Calgary.
Documents show Health Canada inspectors gave Grifols’ Calgary facility on Sunridge Way NE an overall “non-compliant” designation in December 2025.
Donor evaluation issues found
found during inspection The Calgary center did not accurately assess whether donors were suitable, did not collect blood in accordance with its Health Canada authorization, did not thoroughly investigate errors and accidents, and did not take adequate corrective and preventive actions.
It also cited shortcomings in complaint monitoring and management, inadequate staff training and evaluation, and problems with calibration, cleaning or maintenance of critical equipment.
Records were not always accurate or complete, and some operating procedures were not always followed, according to inspection reports.
“The findings raise some concerns not only about donor safety but also about the end products generated from these collections,” said Dr. Brian Tordon, a Calgary-based transfusion medicine specialist.
Based on available information, their main concern is donor evaluation.
“If there were errors or flaws at that time, it could impact both donor security and, again, the integrity of anything made from that donation,” Tordon said.
In an email, a Health Canada spokesperson Said, “None of the observations documented at the Grifols site in Calgary were considered significant.”
“Based on information received by Health Canada“D and reviewed, the integrity of blood components prepared by Grifols’ site in Calgary has not been compromised, and the site is allowed to remain open.”
health canada Grifols ordered to take corrective action in case of non-compliance its blood rules.
The company has three other paid plasma collection centers in Alberta, including two in Edmonton and one in Red Deer.
‘Troubling’ findings
Grifols’ Regina location It was also rated as non-compliant in January. Its Saskatoon facility was found to be non-compliant in 2023, and the Saint John location received the same rating in a 2022 pre-licensing inspection.
“The facts before us are troubling and troubling,” said Andrew Longhurst, a senior researcher at the Canadian Center for Policy Alternatives.
He is calling for greater scrutiny of the plasma industry for profit.
He said, “It raises a lot of concerns about whether Health Canada’s regulatory approach is too pragmatic. And I would argue that we need a much more pragmatic, stronger enforcement and regulatory approach across the country.”
Health Canada said in a statement that the country’s plasma system involves rigorous screening, testing and monitoring and is considered one of the safest in the world.
The company is working ‘fast’ to deal with the problems
Grifols said in a statement that it is working to address the concerns filed in December.
“Donor safety and plasma quality remain our top priorities; and we are committed to ensuring the long-term integrity and reliability of our operations around the world,” a spokesperson wrote in an email to CBC News.
According to Grifols, plasma donation centers face multiple layers of regulatory oversight as well as internal quality controls.
The statement read in part, “The ‘non-compliant’ rating means that the operational processes identified require improvement; and we are working hard to address them expeditiously.”
Grifols said it has submitted detailed action plans to address the Calgary and Regina inspection findings and began implementing changes immediately.
No deaths reported in Alberta
Health Canada, which regulates both paid and unpaid plasma collection facilities, said it has not received any reports of deaths from plasma centers in Alberta since 2015.
The federal agency confirmed that it had received three reports of serious adverse reactions among donors through 2023:
- February 14, 2023: Canadian Plasma Resources, Edmonton.
- March 21, 2023: Canadian Plasma Resources, Calgary.
- July 4, 2023: Canadian Plasma Resources, Calgary.
A fourth report from Grifols’ Calgary location in June 2024 was not confirmed.
Grifols announced plans to purchase Canadian plasma processing centers in June 2023.
“It is important to note that these reports do not mean that any link has been established between the adverse event and the plasma donation procedure,” a Health Canada spokesperson said.
“However, they are an important information source for our ongoing security monitoring.”
The agency said its Calgary inspection includes verifying the centre’s incident investigation, examining records related to the incidents, as well as ensuring standard operating procedures are being followed and adequate qualified staff are in place.
It would not provide further details.
A spokesperson said that when a facility is deemed “non-compliant”, Health Canada will typically return for re-inspection within a year.
The agency said it closely monitors plasma collection centres, and that ““We will not hesitate to take action to reduce the risk to Canadians.”
It is currently overseen by Grifols’ head office in Oakville, Ontario.
No restrictions considered in Alberta
While plasma collection is federally regulated, provinces can decide whether to allow clinics to pay for plasma.
British Columbia, Quebec and Ontario (with some exceptions) have laws prohibiting them, and Manitoba’s health minister recently said restrictions could be an option.
In response to questions after news of the deaths in Manitoba, the Alberta government said it was not considering imposing restrictions.
Kyle Warner, press secretary to Alberta’s Minister of Hospital and Surgical Health Services, said, “Canada is facing a shortage of domestically produced blood plasma and imports most of the plasma it needs from paid donors in the United States. By allowing private plasma donations, including in Alberta, Canada has increased its supply.”
“There are no plans to re-impose restrictions.”
According to Tordon, who is also a clinical assistant professor in the department of pathology and laboratory medicine at the University of Calgary, plasma collected through Grifols is often shipped to the United States for manufacturing before the products are used to treat Canadian patients.
This involves extensive processing and security testing, he said.
“There is nothing that clearly shows that our blood supply is unsafe or that there are widespread issues with the transfusion practices we have in Canada,” Tordon said.
He said that although blood collection is generally safe, there are some inherent risks for donors, including injury, drops in blood pressure and seizures. Some cardiovascular conditions can put the donor at risk for serious problems or even death, he said.
According to Tordon, donor screening is important.
He urges plasma donors to provide their full health and medication history, as well as any previous donation problems, to ensure the process is as safe as possible.
