The inspection of the Oakville facility identified \u2018quality management\u2019 and \u2018processing\u2019 deficiencies. It follows two recent deaths of plasma donors at the company\u2019s clinics.<\/em><\/p>\nA recent Health Canada inspection of embattled pharmaceutical giant Grifols\u2019 head office in Oakville, Ont. identified a number of deficiencies, including problems with how the company assesses the suitability of plasma donors and with the qualifications or training of its personnel.<\/p>\n
The initial results of the inspection, posted recently to a Health Canada website, come as the Spanish pharmaceutical company faces increasing domestic scrutiny after two people recently died following blood plasma donations at the company\u2019s clinics in Winnipeg.<\/p>\n
Grifols, which operates 17 paid plasma collection clinics across Canada, including two in Toronto, has said that it has \u201cno reason to believe that there is a correlation between the donors\u2019 passing and plasma donation.\u201d<\/p>\n
However, some health advocates and politicians have disputed the company’s claim and renewed calls for the federal government to ban pay-for-plasma collection clinics nationwide following the deaths.<\/p>\n
The deficiencies Health Canada identified at Grifols\u2019 Canadian headquarters in Oakville are just the latest in a series of issues flagged by the federal health regulator at several of the company’s for-profit clinics since Grifols began operating in Canada in 2022.<\/p>\n
Over the past three and a half years, four of the company\u2019s clinics have been found out of compliance by Health Canada inspectors.<\/p>\n
This is the same number of non-compliant inspection results as have been issued to all other facilities licensed to collect blood or plasma in Canada combined since 2012, according to the federal health regulator.<\/p>\n
Most recently, Health Canada found a Grifols plasma facility in Regina out of compliance in January and its Calgary facility out of compliance in December.<\/p>\n
In contrast, Canadian Blood Services, the operator of Canada\u2019s blood collection and distribution system outside of Quebec, has never received a non-compliant inspection finding for any of its dozens of clinics nationwide, per Health Canada.<\/p>\n
Natalie Mehra, executive director of advocacy organization Ontario Health Coalition, said the new details about the company\u2019s inspection track record are shocking.<\/p>\n
\u201cI\u2019m outraged,\u201d she said in an interview with TorontoToday. \u201cWe can now see a clear pattern of repeated violations of standards by Grifols.\u201d<\/p>\n
Mehra, whose organization has advocated against the introduction of paid plasma collection centres for years, said Health Canada must move to shut the company\u2019s clinics down.<\/p>\n
\u201c[This] should result now in the cancellation of their licences,\u201d she charged.<\/p>\n
TorontoToday asked Grifols for more information about the deficiencies Health Canada recently identified at its Oakville headquarters, but the company would not comment on an ongoing inspection. In a statement, it said \u201cHealth Canada\u2019s robust inspection framework and associated regulations help us to ensure that we are operating within their guidance and in pursuit of continuous improvement.\u201d<\/p>\n
In response to earlier questions about its inspection track record relative to its peers, Grifols maintained \u201cdonor safety and plasma quality\u201d are its top priorities.<\/p>\n
In an emailed statement, a company spokesperson said it is working to \u201cswiftly\u201d address the deficiencies identified by Health Canada during the recent inspections of its Calgary and Regina clinics.<\/p>\n
Following the two deaths in Winnipeg, TorontoToday endeavoured to reach Health Minister Marjorie Michel to inquire whether a ban on paid plasma clinics is being contemplated, but a spokesperson for the minister did not provide a response, redirecting questions to Health Canada.<\/p>\n
Repeat concerns about donor suitability assessments<\/strong><\/p>\nDuring the inspection of Grifols\u2019 head office, Health Canada inspectors identified an unspecified deficiency with the company\u2019s assessment of plasma donor suitability \u2014 an area of concern that was also flagged at the Regina and Calgary facilities just weeks earlier.<\/p>\n
When TorontoToday visited Grifols\u2019 two plasma donation sites in Toronto last year, several clients entering and exiting the clinic said they donated plasma frequently because they were struggling financially. The company uses social media advertising to draw clients, who are paid on a sliding scale and can receive bonuses the more often they donate.<\/p>\n
For example, Grifols will pay a \u201cbonus\u201d of $100 if an individual gives blood plasma 100 times in a calendar year.<\/p>\n
In an emailed statement to TorontoToday, Health Canada said the inspection of Grifols\u2019 Regina site found that in at least one case, the company collected a donor\u2019s plasma twice within 48 hours, a violation of its federal licence.<\/p>\n
In Ontario, Grifols is acting as an \u201cagent\u201d of Canadian Blood Services (CBS), allowing the company to skirt the province\u2019s ban on paid plasma collection. In 2019, Health Canada permitted the company to extract plasma at double the rate of the CBS.<\/p>\n
While CBS is allowed to extract plasma from an individual once every six days, with a maximum of 52 times per year, Grifols is permitted to collect every two days (with a maximum of twice in a seven-day period), up to a maximum of 104 draws per year.<\/p>\n
A recent meta study found that twice-weekly plasma collection can cause negative health impacts for donors, including impacting an individual\u2019s levels of immunoglobulin, an infection-fighting antibody, and potentially leading to iron deficiency.<\/p>\n
Concerns identified with respect to accident response<\/strong><\/p>\nSeparately, the non-compliant inspections at Grifols’ clinics in Regina and Calgary also found the company\u2019s \u201cvalidation, calibration, cleaning, or maintenance of critical equipment were not always sufficient,\u201d and that the clinics \u201cdid not thoroughly investigate errors and accidents and determine corrective and preventive actions.\u201d<\/p>\n
The Oakville inspection also identified several deficiencies in the area of quality management.<\/p>\n
The inspection, which began about three months after a 22-year-old international student died after donating plasma at one of the company\u2019s Winnipeg clinics, found problems with Grifols\u2019 operating procedures and \u201cpersonnel qualifications or training,\u201d as well as a failure to meet Health Canada\u2019s \u201caccident investigation and\/or reporting requirements.\u201d<\/p>\n
Could more action be taken?<\/strong><\/p>\nMehra said Health Canada must answer for why it has not taken more proactive steps to ensure Grifols’ clinics are operating in compliance with federal rules.<\/p>\n
\u201cWhy are there no consequences for Grifols for repeated non-compliance across the country?\u201d she asked. \u201cIt appears they\u2019ve been allowed to expand.\u201d<\/p>\n
After a finding of non-compliance, the federal health minister may choose to suspend all or part of an establishment\u2019s licence.<\/p>\n
Canada\u2019s laws also mandate that the minister must cancel an operator\u2019s licence to collect blood or blood components if \u201cthe establishment\u2019s compliance history demonstrates an inability to consistently conduct its activities in accordance with\u201d the regulations.<\/p>\n
The minister has not taken any such steps with Grifols.<\/p>\n
In an emailed statement, Health Canada said following non-compliant inspections at Grifols’ clinics in Saint John, NB, in 2022 and in Saskatoon, SK, in 2023, Health Canada conducted re-inspections about eight months later and confirmed the company\u2019s planned corrective actions had been implemented.<\/p>\n
Health Canada said the inspection process for non-compliant cases in Calgary and Regina are still ongoing.<\/p>\n
As for the head office inspection, the federal regulator said it will \u201cnot hesitate to take action\u201d should a finding of non-compliance be identified.<\/p>\n
Grifols summoned to appear before federal committee<\/strong><\/p>\nOn Thursday afternoon, a Grifols executive is set to appear before the House of Commons\u2019 Standing Committee on Health as part of its examination of Canada\u2019s “pharmaceutical sovereignty.\u201d<\/p>\n
Grifols was invited by the committee to appear at a meeting earlier in March, but declined. The committee responded to the refusal by taking the rare step of summoning a Grifols executive \u2014 a legally binding order.<\/p>\n
In an interview with TorontoToday on Wednesday, Conservative MP Matt Strauss, a medical doctor who sits on the health committee, said he believes there are many unanswered questions the company must address in wake of the deaths linked to its Winnipeg clinics.<\/p>\n
Either something \u201castoundingly statistically improbable \u2014 or something quite medically incorrect has occurred,\u201d he said of the deaths.<\/p>\n
\u201cThis is simply unheard of, and constituents in my riding are just, in general, concerned about the practice of paying for any sort of blood plasma, or tissue donation,\u201d he said.<\/p>\n
An agenda for the meeting indicates the company\u2019s vice-president of sales and commercial operations, Mary Hughes, is expected to appear before the committee.<\/p>\n
Hughes may also be called upon to answer questions about reporting by the Globe and Mail that found Grifols has sold medicine to other countries that was made from Canadian-donated plasma \u2014 something Canadian Blood Services promised would not occur.<\/p>\n
The report prompted several Conservative MPs to call for a parliamentary investigation of the Spanish drugmaker. Strauss said the committee did not decide to move forward with the probe, but that he and other committee members will ask questions on Thursday.<\/p>\n
Editor\u2019s note: This story has been updated with a response from Grifols that was not received until after publication.<\/em><\/p>\nClick here for the original article<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"(March 26, 2026) By: Gabe Oatley, TorontoToday The inspection of the Oakville facility identified \u2018quality management\u2019 and \u2018processing\u2019 deficiencies. It follows two recent deaths of plasma donors at the company\u2019s clinics. A recent Health Canada inspection of embattled pharmaceutical giant Grifols\u2019 head office in Oakville, Ont. identified a number of deficiencies, including problems with how […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21],"tags":[],"class_list":["post-31332","post","type-post","status-publish","format-standard","hentry","category-ohc-in-the-news"],"yoast_head":"\n
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