Form 3486 Biological Product Deviation Report

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

0458 FDA-3486

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

OMB: 0910-0458

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

BIOLOGICAL PRODUCT DEVIATION REPORT

FDA USE ONLY

Date Received:

     

Date Reviewed:

     

BPD ID:

     

BPD No.

* Indicates required information

     

A. FACILITY INFORMATION

B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION

1. Reporting Establishment Information

1. Establishment Tracking #

     

* Reporting Establishment Name

2. Date BPD Occurred

     

     

* Street Address Line 1

3. * Date BPD Discovered

     

     

Street Address Line 2

4. * Date BPD Reported

     

     

* City

* State

5. * Description of BPD (use Page 2 for additional space)

     

  

     

Country

*Zip Code

     

     

* Point of Contact

     

* Telephone #

6. * Description of Contributing Factors or Root Cause

(     )      

(use Page 3 for additional space)

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 onto Section B1.

* Establishment Name

     

Street Address Line 1

8. * Please Enter the 6 Character BPD Code

     


.Street Address Line 2
















     







 

 


 

 


 

 


* City

* State


     

  

C. UNIT / PRODUCT INFORMATION

* Country

* Zip Code

Please check the type Blood (Continued on Page 5)

of product:

Non-Blood (Continued on Page 6)

     

     

4. Establishment Identification Number:

FDA Registration #

     

CLIA #

     



Biological Product Deviation Report

B5. DESCRIPTION OF BPD (continued)

     



Biological Product Deviation Report

B6. DESCRIPTION OF CONTRIBUTING FACTORS OR ROOT CAUSE (continued)

     



Biological Product Deviation Report

B7. FOLLOW-UP (continued)

     



Biological Product Deviation Report

C1. BLOOD PRODUCTS / COMPONENTS

TOTAL NUMBER OF LOTS:

     





Unit #

Collection Date (MM/DD/YYYY)

Expiration Date (MM/DD/YYYY)

Product Code

Disposition

Notification

(Y,N,RN**)

1.)

     

     

     

     

     

     

2.)

     

     

     

     

     

     

3.)

     

     

     

     

     

     

4.)

     

     

     

     

     

     

5.)

     

     

     

     

     

     

6.)

     

     

     

     

     

     

7.)

     

     

     

     

     

     

8.)

     

     

     

     

     

     

10.)

     

     

     

     

     

     

11.)

     

     

     

     

     

     

12.)

     

     

     

     

     

     

13.)

     

     

     

     

     

     

14.)

     

     

     

     

     

     

15.)

     

     

     

     

     

     

16.)

     

     

     

     

     

     

17.)

     

     

     

     

     

     

18.)

     

     

     

     

     

     



Biological Product Deviation Report

C2. NON-BLOOD PRODUCTS

TOTAL NUMBER OF LOTS:

     





Lot #

Expiration Date (MM/DD/YYYY)

Product Type

Product Code

Disposition

Notification

(Y, N)

1.)

     

     

     

     

     

     

2.)

     

     

     

     

     

     

3.)

     

     

     

     

     

     

4.)

     

     

     

     

     

     

5.)

     

     

     

     

     

     

6.)

     

     

     

     

     

     

7.)

     

     

     

     

     

     

8.)

     

     

     

     

     

     

10.)

     

     

     

     

     

     

11.)

     

     

     

     

     

     

12.)

     

     

     

     

     

     

13.)

     

     

     

     

     

     

14.)

     

     

     

     

     

     

15.)

     

     

     

     

     

     

16.)

     

     

     

     

     

     

17.)

     

     

     

     

     

     

18.)

     

     

     

     

     

     



Biological Product Deviation Report

D. ADDITIONAL COMMENTS

     


Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, adhering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research

Office of Compliance and Biologics Quality

1401 Rockville Pike, Suite 200N, HFM-600

Rockville, MD 20852-1148

An agency may not initiate a collection activity without first obtaining OMB approval. The approved collection instrument should display a current and valid OMB control number, expiration date, public protection provision, and a burden statement on the approved collection instrument.

FORM FDA 3486 (7/04) Page 8 of 8

File Typeapplication/msword
AuthorBrian Perry
Last Modified ByJonna Capezzuto
File Modified2007-02-05
File Created2007-02-05

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