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  1. Center for Drug Evaluation and Research (CDER)

CDER - Biological Product Deviations

FDA requires reporting of certain deviations and unexpected events in manufacturing.

The manufacturer of a CDER-regulated product that holds the biological product license and had control over the product when a deviation or unexpected event associated with manufacturing occurred, is required to submit Biological Product Deviation Reports (BPDR) to FDA if the safety, purity, or potency of a distributed product may be affected. Per regulation 21 CFR 600.14, the manufacturer must report such events associated with testing, processing, packing, labeling, storage, holding, or distribution.

A manufacturer is required to report these deviations and unexpected events to the FDA as soon as possible, but not later than 45 calendar days from the date of discovery of information that reasonably suggests a reportable event has occurred. For more information on when and what to report, refer to: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Guidance for Industry.

Reports should be submitted to CDER-BPDR@fda.hhs.gov using Form FDA 3486. To facilitate prompt processing of all incoming BPDRs, CDER strongly recommends that all information relevant to the BPDR be submitted in the Form FDA 3486. This should include the initial submission and all subsequent follow up or final submissions. Custom reports attached to Form FDA 3486 or any submissions without Form FDA 3486 is discouraged. Please refer to General Recommendations for Completing CDER-Regulated Biological Product Deviation Report (BPDR) and General Instructions for Form FDA 3486.

Though the electronic form is strongly encouraged, the form can also be mailed to:

Food and Drug Administration, CDER
Office of Pharmaceutical Quality
Office of Quality Surveillance
Attn: CDER DQRS Reports – BPDR Assessment
10903 New Hampshire Ave. Bldg. 75, Rm 6654
Silver Spring, MD 20993-0002

For BPDRs for products regulated by the Center for Biologics Evaluation and Research (CBER), such as allergenics, derivatives, in-vitro diagnostics, vaccines, and nonreproductive human cells, tissues, and cellular and tissue‑based products, refer to the CBER BPDR website.

For combination products that are regulated as BLAs at CDER, you should submit any BPDRs to CDER at CDER-BPDR@fda.hhs.gov using Form FDA 3486. However, there are some unique considerations for combination products and the information that should be submitted. For additional information on BPDRs for combination products, refer to Postmarket Safety Reporting for Combination Products guidance.

For CDER BPDR electronic submission, email completed Form FDA 3486 to: CDER-BPDR@fda.hhs.gov.

Questions and inquiries regarding BPDRs to CDER should be directed to: CDERDQRSREPORTS@fda.hhs.gov.

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