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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Electronic Submission of Biological Product Deviation Reports (eBPDR)

Biological Product Deviation Reports can now be submitted electronically via the Internet.

A valid Registration or CLIA Number is required to use this system. If you do not have a valid Registration Number or CLIA Number, you will be unable to access the electronic form. Contact your local FDA district office to obtain your Registration Number from the appropriate Registration Monitor (Blood, Device, or Drug). For a valid CLIA number, contact your CLIA State Survey Agency on the Centers for Medicare & Medicaid Web site.

In order to use this online system, you must have Netscape Navigator 4.7 or higher, or Microsoft Internet Explorer 5.0 or higher.

Please note: eBPDR moved to a new URL on October 1, 2002. There is a re-direct page at this location with the new URL. This change is to give you increased security by moving to a secure 'https' site, and by requiring username/passwords to access eBPDR. If you have any questions/concerns, please contact us.

If you have a valid Registration Number or CLIA Number and the appropriate browser version, you may access the Electronic Submission of Biological Product Deviation Reports System.

If you are unable to utilize the online system, your report may be submitted by mail using the Biological Product Deviation Report Form, available in PDF format. Instructions for filling out the form and necessary codes are available on the main Biological Product Deviation Reporting page. After downloading the form, print it, complete it as instructed and return the form to the address under "Contact Us" below:

 

Contact FDA

(240) 402-9160
Biological Product Deviation Reporting (CBER)

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center

10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002