How to report fatal blood-related reactions to the Food and Drug Administration

1. Report the event by phone if it involved a donor fatality associated with plasmapheresis. For all other reports, call or email during regular business hours.
2. Conduct a thorough investigation and maintain a written report. In the case of a transfusion reaction, if you determine the blood product was at fault, forward a copy of the report to the manufacturer or
   collecting facility.
3. Within 7 days of the fatality, submit a written report of the investigation to the Director of Office of Compliance and Biologics Quality by email, fax or mail.

Tips:

• Plasmapheresis in defined by the FDA as “the procedure in which blood is removed from the donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the donor.” 21 CFR § 606.3.

Resources:

• FDA, “Transfusion/Donation Fatalities
• Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
• Laws: 21 CFR §§ 606.3, 606.170

Contact:

U.S. Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
Office of Compliance and Biologics Quality (OCBQ)
Phone: (240) 402-9160
E-mail: fatalities2@fda.hhs.gov
Fax: 301-595-1304
Website: Transfusion and donation fatalities

Mailing Address for 7-Day Report:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

We hope these instructions helped you meet this reporting requirement. Be aware that this action may not fulfill all applicable reporting requirements associated with the event.

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