Electronic Submission of Biological Product Deviation Reports (eBPDR)
We encourage submitting Biological Product Deviation Reports electronically through the CBER eBPDR web application.
A valid Registration [FDA Establishment Identifier (FEI)] 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. Please use the link to FDA’s FEI Search Portal at https://www.accessdata.fda.gov/scripts/feiportal. This portal will allow you to look up your own FEI number(s) and obtain your registration information. There is no charge to create an account. If you have difficulty accessing your information via the portal, you may contact the registration staff below to obtain your firm’s information.
CBER (Blood Establishments): email@example.com
CBER (Human Tissue): firstname.lastname@example.org
CDER (Drugs): email@example.com
CDRH: (Devices): firstname.lastname@example.org
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
- Mozilla Firefox 43.0 or newer
- Google Chrome 49.0 or newer
- Microsoft Internet Explorer (with Compatibility View disabled)
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 in the General Instruction for Completing the BPDR Form FDA3486.
- CBER eBPDR FIS Login
- Biological Product Deviation Reporting (BPDR) CBER Contact Information
- Biologic Forms
- Instructions for Using the eBPDR System
- Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
- Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
- Biological Product Deviation Reporting - Blood Product Codes
- ORA FIELD PROGRAM MONITORS