Laura HieronymusSenior Recall Coordinator, CBER

Office of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Food and Drug Administration

CBER’s Direct Recall Classification

Program

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Understand CBER’s Direct Recall Classification (DRC) Program.

Learn how to access your establishment’s Additional Information (AI) report through CBER On-Line.

Learn how to submit Additional Information (AI) reports to CBER for recall classification purposes.

Objectives

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CBER On-Line – Main Menu

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eBPDR – Reporting Establishment Information

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eBPDR – Biological Product Deviation (BPD) Information

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eBPDR – Description of Biological Product Deviation

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eBPDR – Description of Contributing Factors for BPD

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eBPDR – Description of Follow-Up for BPD

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eBPDR: Electronic Biological Product Deviation Report - Preview

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Electronic Biological Product Deviation Receipt Confirmation

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From: CBER_RecallAlerts@fda.hhs.govTo: jane.doe@eyebank.com; sally.jones@eyebank.comSubject: BPD Additional Information (AI)- Conf # 300943, Facility # 1234567890

Thank you for your electronic submission of the Biologic Product Deviation Report (BPDR) or HCT/P Deviation Reportreferenced below. The Center for Biologics Evaluation and Research has completed an initial review of thisBPDR. Additional information is necessary to complete our review for possible recall classificationpurposes.

The web form used to provide CBER this additional information is available athttps://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm

Access to the form requires the BPDR submitter's username and password.Upon login, access the electronic BPDR System (eBPDR) and select "Unfinished Reports".

FEI# : 1234567890 BPD Confirmation# : 300943 BPD Submitted Date : 06/28/2013Establishment Tracking# : 0012013 Note: To provide BPD Additional Information (AI) access to multiple authorized representatives, you may create a singleuser account to submit future BPD reports.

Thank You,CBER Recall CoordinatorFood and Drug Administration

BPDR Email Communication

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CBER On-Line - Main Menu

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eBPDR - Unfinished Reports

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BPD AI - Updated Product Disposition

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BPD AI - Notification Method

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BPD AI - Distribution Pattern Information

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BPD AI - Distribution Pattern Information (cont.)

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BPD AI - Industry Recall Contacts

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BPD AI - Industry Recall Contacts (cont.)

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BPD AI - Preview Report

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BPD AI – Preview Report/ Industry Recall Contacts

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BPD AI - Submitted Report

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BPD AI - Submitted Report/Industry Recall Contacts

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ORA R&E – Classification Letters

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www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

Event ID 12345

Product Type Corneas

Status Completed

Recalling Firm Eye Bank, Inc.

City Rockville

State Maryland

Country US

Voluntary/Mandated Voluntary; Firm Initiated

Recall Initiation Date 06-03-2013

Initial Firm Notification Telephone

Distribution Pattern MD, PA

Enforcement Report Event Detail

26http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

Product Description

Code Information

Classification Reason for Recall

Product Quantity

Recall Number

Corneas Lots 123 & 456

Class II Corneas, recovered from an ineligible donor, were distributed.

2 Corneas

B-0123-13

Enforcement ReportProduct Detail

2727

• Phone: toll-free 1-800-835-4709 (or 301-827-1800)• E-mail: ocod@fda.hhs.gov• On the web:

http://www.fda.gov/BiologicsBloodVaccines/default.htm• Follow us on Twitter: http://twitter.com/#!/FDACBER

Questions about today’s webinar?