Statement from Health Canada on false claims made by the Cord Blood Bank of Canada
August 9, 2021 | Ottawa, ON | Health Canada
Health Canada is aware that the Cord Blood Bank of Canada (CBBC) is making claims on its website that Health Canada's recent site visit led to the company having no option but to remove cord blood units and related samples under its control from cryogenic storage. These claims are false and Health Canada wishes to set the record straight.
Health Canada inspectors conducted an unannounced site visit of CBBC on August 4, 2021. The purpose was to verify CBBC's compliance with the Food and Drugs Act, including the storage conditions of the cord blood units.
Health Canada determined a site visit was necessary when it received information raising questions about whether CBBC was storing samples under proper temperature control and sanitary conditions, and meeting all regulatory requirements. It was also prompted because CBBC did not provide relevant and sufficient information to Health Canada when requested.
On the day of the site visit, CBBC took the decision to remove all of the samples stored on site out of its cryogenic storage tanks prior to providing the inspectors access to the premises.
At no point has Health Canada given any indication verbally or in writing to CBBC that it should remove cord blood under its control from cryogenic temperatures or cease to maintain samples, or that these actions were necessary to meet requirements of the Food and Drugs Act. Contrary to CBBC claims, Health Canada has also never indicated that CBBC clients should not be afforded a hearing regarding the cord blood units.
Health Canada's assessment and verification of compliance is ongoing. CBBC, like all banks that store cord blood, must meet requirements under the Food and Drugs Act (FDA) and its applicable regulations. This is the overarching legislation for the safety of therapeutic products sold or distributed in Canada, which stipulates that products cannot be sold if they were manufactured, prepared, preserved, packaged or stored under unsanitary conditions. Health Canada has the authority to take action under the FDA if it becomes aware of non-compliance or potential safety concerns.
Health Canada encourages anyone with potential safety concerns involving cord blood stored at any cord blood bank to report them to Health Canada.
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