Health Canada report finds Grifols cleared ineligible plasma donors

A Health Canada inspection report found that Grifols cleared multiple donors at risk for Creutzfeldt-Jakob disease and operated one Winnipeg centre above its daily capacity limit. , head office and noted that two donors previously deferred for possible exposure to a rare variant linked to mad cow disease had their deferrals lifted even though they continued to meet exclusion criteria.

On May 23, 2025, Grifols also lifted deferrals for donors with a family history of the disease, and additional deferrals were lifted on May 28 without a full review of the deferred-donor list.

Capacity and supervision findings The same inspection noted that 119 donors presented at one Winnipeg centre on Jan. 3, 2025, when only one physician substitute was available. The following day, the centre collected plasma and assessed donor eligibility without any physician substitute on site.

Health Canada records list a daily maximum of 100 donors per physician substitute. A Grifols spokesperson said the company is addressing the deficiencies and that no plasma units were collected from donors who met exclusion criteria. The company also said it changed its Creutzfeldt-Jakob exclusion criteria in March 2025 after receiving Health Canada approval.

Reported adverse reactions Health Canada data show 25 serious adverse reactions, including cardiac arrest and pulmonary embolism, reported since 2018 at centres now operated by Grifols. Two deaths occurred in Winnipeg in October 2025 and January 2026 after plasma donations at different Grifols locations.

A personal injury lawyer representing affected donors said his firm is exploring legal options and believes additional injured donors may exist. Health Canada did not respond to requests for comment on the findings or on a separate June 4 inspection of a Grifols location in Etobicoke, Ont.