Direct Recall Classification Program (Blood and Plasma)

CBER’s Direct Recall Classification (DRC) program provides blood and plasma establishments the opportunity to electronically report recall related information directly to CBER.  The standardized reporting established for the submission of electronic Biological Product Deviation Reports (eBPDRs) has been expanded to collect Additional Information (AI) necessary for recall classification purposes. 

Electronically submitted eBPDRs that represent a potential recall situation and contain 18 or fewer components are candidates for DRC.  Currently, for recall classification purposes, eBPDRs that contain greater than 18 components require collection of recall documentation through the local district office. 

Following CBER’s review of a submitted eBPDR that represents a recall situation, an e-mail notification from CBER_RecallAlerts is sent to both the eBPD submitter and eBPD contact.  This e-mail notification requests the submitter re-access the CBER On-Line Log-In Screen from the provided link and complete BPD Additional Information (AI) for recall classification purposes.  E-mail notifications from CBER_RecallAlerts are sent for each AI report that FDA is requesting be completed.

The DRC application consists of four screens of information used to electronically capture recall details.  The first page is the BPD AI – Updated Product Disposition Page, followed by the BPD AI - Notification Method, Distribution Pattern Information, and Industry Recall Contacts.  The user then has the opportunity to preview their report and submit to FDA.

Each screen in the DRC application contains on-screen instructions and displays the Reporting FEI, BPD Confirmation Number, Reporting Establishment Name, Tracking Number, and today’s date.

Collection of BPD Additional Information (BPD AI) for Recall Classification Purposes

General Instructions

If you need assistance or have a question, you may e-mail CBER_RecallAlerts@fda.hhs.gov.