Includes Human Tissue and Cellular and Tissue-Based Product (HCT/P) Deviation Reporting
FDA requires reporting of certain deviations and unexpected events in manufacturing in accordance with 21 CFR 600.14, 606.171 or 1271.350(b).
The following manufacturers, who had control over the product when an event associated with manufacturing (deviation or unexpected event) occurred, are required to submit Biological Product Deviation (BPD) reports to the Food and Drug Administration (FDA), if the safety, purity, or potency of a distributed product may be affected:
- Manufacturers of licensed biological products other than blood and blood components (licensed non‑blood) who hold the biological product license [21 CFR 600.14];
- Licensed manufacturers of blood and blood components, including Source Plasma [21 CFR 606.171];
- Unlicensed registered blood establishments [21 CFR 606.171]; and
- Transfusion services [21 CFR 606.171].
Manufacturers of nonreproductive human cells, tissues, and cellular and tissue‑based products (HCT/Ps) regulated by FDA solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 are required to submit HCT/P deviation reports to the FDA/Center for Biologics Evaluation and Research [21 CFR 1271.350(b)], if the deviation or unexpected event involving a distributed product is related to a Core Current Good Tissue Practice requirement [21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination.
A manufacturer is required to report to the FDA as soon as possible, but not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred.
Reports should be submitted using FDA Form 3486. The report may be submitted electronically to CBER or in paper form by mail. Instructions on completing the form are available. There are links below for the list of biological product deviation reporting and HCT/P deviation reporting codes; the list of blood product codes; and the list of non-blood product codes, to include allergenics, derivatives, in-vitro diagnostics, therapeutics, vaccines, and HCT/Ps. The biological product deviation codes are used to categorize the deviation or unexpected event. The use of these codes will assist the FDA in analyzing the data submitted and streamline the trend analysis process. The product codes are used to identify the product(s) affected.
Biological product deviations reports required by 21 CFR 600.14, 21 CFR 606.171, or 21 CFR 1271.350(b), involving a product regulated by the Center for Biologics Evaluation and Research should be submitted electronically (Electronic Submission of Biological Product Deviation Reports (eBPDR) | FDA) or sent to: sent to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Refer to CDER - Biological Product Deviations | FDA for biological product deviations reports required by 21 CFR 600.14, involving a therapeutic product regulated by the Center for Drugs Evaluation and Research.
Forms & Instructions
- General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
- Instructions for Using the eBPDR System
- Direct Recall Classification Program
CBER's Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER.
- Electronic Submission of Biological Product Deviation Reports (eBPDR)
- Biological Product Deviation Guidances & Rules
- Biological Product Deviation Report
- 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
Reports & Publications
Questions About Submitting a Report
- Biological Product Deviation Reporting (BPDR) CBER Contact Information
- Refer to CDER - Biological Product Deviations | FDA questions regarding reporting to CDER.