Form 3486 Biological Product Deviation Report

FDA USE ONLY

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Date Received:

BIOLOGICAL PRODUCT DEVIATION REPORT

Date Reviewed:
BPD ID:
BPD No.

* Indicates required information

A. FACILITY INFORMATION

B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION
1. Establishment Tracking #

1. Reporting Establishment Information

2. Date BPD Occurred

* Reporting Establishment Name

3. * Date BPD Discovered

* Street Address Line 1

4. * Date BPD Reported
Street Address Line 2
5. * Description of BPD (use Page 2 for additional space)
* City

* State

Country

* Zip Code

* Point of Contact
6. * Description of Contributing Factors or Root Cause
(use Page 3 for additional space)

* Telephone #
E-mail
2. * Reporting Establishment Identification Number
FDA Registration #
CLIA #

7. * Follow-Up (use Page 4 for additional space)
3. If the BPD occurred somewhere other than the above
facility, please complete this Section and Section A4;
otherwise, continue on to Section B1.
* Establishment Name

Street Address Line 1
8. * Please Enter the 6 Character BPD Code

Street Address Line 2
* City

* State

* Country

Zip Code

4. Establishment Identification Number

C. UNIT / PRODUCT INFORMATION

Please check the type
of product:

FDA Registration #

Blood

(Continued on Page 5)

Non-Blood

(Continued on Page 6)

CLIA #
FORM FDA 3486 (10/12)

Form Approved:
OMB No. 0910-0458
Expires: 1/31/2014
See PRA Statement on Page 8.

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Biological Product Deviation Report
B5. DESCRIPTION OF BPD (continued)

FORM FDA 3486 (10/12)

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Biological Product Deviation Report
B6. DESCRIPTION OF CONTRIBUTING FACTORS OR ROOT CAUSE (continued)

FORM FDA 3486 (10/12)

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Biological Product Deviation Report
B7. FOLLOW-UP (continued)

FORM FDA 3486 (10/12)

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Biological Product Deviation Report
C1. BLOOD PRODUCTS / COMPONENTS

TOTAL NUMBER OF UNITS:
Unit #

Collection Date
(MM/DD/YYYY)

Expiration Date
(MM/DD/YYYY)

Product Code

Disposition

1.)

2.)

3.)

4.)

5.)

6.)

7.)

8.)

9.)

10.)

11.)

12.)

13.)

14.)

15.)

16.)

17.)

18.)

FORM FDA 3486 (10/12)

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Notification
(Y,N,RN)

Biological Product Deviation Report
C2. NON-BLOOD PRODUCTS

TOTAL NUMBER OF LOTS:
Lot #

Expiration Date
(MM/DD/YYYY)

Product Type

Product Code

Disposition

1.)

2.)

3.)

4.)

5.)

6.)

7.)

8.)

9.)

10.)

11.)

12.)

13.)

14.)

15.)

16.)

17.)

18.)

FORM FDA 3486 (10/12)

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Notification
(Y,N)

Biological Product Deviation Report
D.

ADDITIONAL COMMENTS

FORM FDA 3486 (10/12)

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Biological product deviation reports required by 21 CFR 600.14, 21 CFR 606.171, or 21 CFR 1271.350(b), involving products
regulated by the Center for Biologics Evaluation and Research (CBER), mail to:
Director, Office of Compliance and Biologics Quality (HFM-600)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

Biological product deviation reports required by 21 CFR 600.14, involving licensed biological products regulated by the Center
for Drug Evaluation and Research (CDER), mail to:
Division of Compliance Risk Management and Surveillance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 2 hours per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

FORM FDA 3486 (10/12)

"An agency may not conduct or sponsor, and
a person is not required to respond to, a
collection of information unless it displays a
currently valid OMB control number."

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