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                Report a Problem to the Center for Biologics Evaluation & Research

Report a Problem to the Center for Biologics Evaluation & Research

                        Biological Product Deviations
          Good Tissue Practices (GTP) & Reporting
          Transfusion/Donation Fatalities
          Direct Recall Classification Program
          Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting


                        Vaccine Adverse Events Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
          Transfusion/Donation FatalitiesReport a Problem to the Center for Biologics Evaluation & Research Transfusion/Donation Fatalities
  
  	
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    Print**Notification Process for Transfusion Related Fatalities and Donation Related Deaths**

Section 606.170(b) of Title 21, Code of Federal Regulations (21 CFR 606.170(b)), requires that facilities notify the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), as soon as possible after confirming a complication of blood collection or transfusion to be fatal. The collecting facility is to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a report of the investigation within 7 days after the fatality.

To report a fatality during regular business hours, call or email our fatality program contact within the Division of Inspections and Surveillance. Outside of regular business hours, you may submit your initial notification by leaving a voice message, or sending an email or facsimile.

Voice-mail: 240-402-9160

E-mail: fatalities2@fda.hhs.gov

Fax: 301-837-6256

Express mail: See address below

We will contact you as soon as possible to obtain more detailed information. This does not replace the 7-day written report regarding the fatality and all related information that we require pursuant to 21 CFR 606.170(b).

Send your 7-day written report to:
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

Annual Summary Fatalities Reported to FDA Following Blood Collection and Transfusion older than 2 years are available on FDA Archive.

Refer to the Following Documents for Additional Information:

Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2021

Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2020

Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2019

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2018

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2017

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2016

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2015 - ARCHIVED

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2014 - ARCHIVED

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2013 - ARCHIVED

Transfusion Related Acute Lung Injury (TRALI) - ARCHIVED

                                                                                  Content current as of:
      09/22/2023
              
              
Regulated Product(s)
		 BiologicsReport a Problem to the Center for Biologics Evaluation & Research

          
                        Biological Product Deviations
          Good Tissue Practices (GTP) & Reporting
          Transfusion/Donation Fatalities
          Direct Recall Classification Program
          Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting


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