Grifols announced on Thursday that it is suspending plasma collection at every clinic in Canada. The decision, described as voluntary, follows a Health Canada inspection that identified several compliance shortfalls at the company's facilities.
Regulatory findings
Health Canada released a summary of its investigation on the same day, noting deficiencies in the validation, calibration, cleaning and maintenance of critical equipment, as well as gaps in staff qualification records and competency assessments. The agency issued a notice of non‑compliance for the Winnipeg site and has previously issued six such notices for clinics in New Brunswick, Saskatchewan, Alberta, Ontario and Manitoba.
An inspection remains underway at the Etobicoke clinic in Ontario. The regulator stressed that the temporary suspension does not threaten the safety of Canada's blood supply and that it will continue to work with Grifols to resolve the issues before any site reopens.
Implications for Canadian plasma supply
Canada relies on imported plasma‑derived medicines for treatments ranging from immune deficiencies to clotting disorders. A pause in domestic collection could tighten supply chains, although the immediate impact is expected to be limited given the modest share of national plasma volume that Grifols provides.
Advocates have long called for an end to paid plasma donation, citing the deaths of two donors at the Winnipeg clinic. A family spokesperson said an autopsy linked one death to an enlarged heart that could not withstand the stress of donation. Health Canada, however, found no direct link between the fatalities and the donation process.
Grifols reiterated that donor safety has never been compromised and pledged full cooperation with the regulator. The company said it is ready for an open, transparent dialogue to address the concerns raised.
Stakeholders will be watching how quickly the compliance gaps are remedied, as the pause highlights the tension between for‑profit plasma collection models and the need for a reliable, safe supply of life‑saving therapies in Canada.
Based on reporting by Global News.