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  4. Report a Problem to the Center for Biologics Evaluation & Research
  5. Direct Recall Classification Program
  1. Report a Problem to the Center for Biologics Evaluation & Research

Direct Recall Classification Program

What is DRC?

Direct Recall Classification (DRC) refers to the classification of biologics recalls directly by personnel in the Center for Biologics Evaluation and Research in lieu of more traditional methods that require additional hours of work by personnel located in each FDA program office. DRC was designed to utilize current information technology to streamline recall classification of CBER-regulated products. Through the use of an electronic interface between two existing agency databases, the time and resources previously needed to review and classify recalls of CBER-regulated products have been greatly reduced.

Following CBER’s review of a submitted electronic Biological Product Deviation Report (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 electronic Biological Product Deviation Reports module (eBPDR) from the provided link and complete BPD Additional Information (AI) requests for recall classification purposes. E-mail notifications from CBER_RecallAlerts are sent for each AI report that FDA is requesting be completed.

What does DRC mean for me?

  • If you are a consumer, DRC means that recalls of CBER-regulated products are posted in the public domain in a timely manner.
  • If you are member of the biologics industry, you will be able to electronically provide information to FDA regarding a recall, thus reducing the burden of copying manual records and sending them to an FDA program office. DRC also facilitates communications with the agency to answer questions or to gather more information regarding a recall.
  • Performance measures for classification of recalls though the use of DRC is monitored through (FDA-TRACK).
  • For the agency, as well as for the public, DRC decreased the resources needed to classify and publish recalls, and allows the reallocation of resources to other agency priorities related to protection of the public health.

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.

Key Resources

 
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