Form FDA 3486 PDF Details

The FDA 3486 form, a critical document disseminated by the Department of Health and Human Services and specific to the Food and Drug Administration, plays a pivotal role in ensuring the safety and efficacy of biological products. Integral to regulatory compliance, it facilitates the comprehensive reporting of any deviations encountered during the manufacturing, testing, storage, or distribution phases of biological product lifecycle. Through detailed sections that require the submission of establishment information, a thorough description of the biological product deviation (BPD), contributing factors or root causes, and follow-up actions, the form embodies a rigorous approach to maintaining product integrity and protecting public health. Each segment, deliberately constructed, calls for precise data, including the establishment’s identification number, the exact nature and timings of the BPD, and proactive measures taken in response, ensuring a systematic capture of potential quality concerns. Furthermore, the classification of the product as either blood or non-blood indicates the form’s applicability across a wide spectrum of biological entities, highlighting its significance in the continuous effort to uphold standards within the healthcare sector.

QuestionAnswer
Form NameForm FDA 3486
Form Length8 pages
Fillable?Yes
Fillable fields1
Avg. time to fill out2 min 12 sec
Other namesform fda 3486, fda form 3486 instructions, fda 3486 form, frm 3486

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

 

 

 

FDA USE ONLY

FOOD AND DRUG ADMINISTRATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date Received:

 

 

 

 

 

BIOLOGICAL PRODUCT DEVIATION REPORT

 

Date Reviewed:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BPD ID:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Indicates required information

 

 

 

BPD No.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. FACILITY INFORMATION

 

B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1. Reporting Establishment Information

1.

Establishment Tracking #

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Reporting Establishment Name

 

2.

Date BPD Occurred

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* 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 on to 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. Establishment Identification Number

 

Please check the type

Blood

 

 

 

 

 

(Continued on Page 5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

of product:

 

 

 

 

 

 

 

 

 

 

 

 

FDA Registration #

 

Non-Blood

 

 

 

 

 

(Continued on Page 6)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CLIA #

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 3486 (10/12)

Form Approved:

Page 1 of 8

 

OMB No. 0910-0458

 

 

 

Expires: 1/31/2014

 

PSC Publishing Services (301) 443-6740 EF

See PRA Statement on Page 8.

Biological Product Deviation Report

B5. DESCRIPTION OF BPD (CONTINUED)

FORM FDA 3486 (10/12)

Page 2 of 8

 

Biological Product Deviation Report

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

FORM FDA 3486 (10/12)

Page 3 of 8

 

Biological Product Deviation Report

B7. FOLLOW-UP (CONTINUED)

FORM FDA 3486 (10/12)

Page 4 of 8

 

Biological Product Deviation Report

C1. BLOOD PRODUCTS / COMPONENTS

TOTAL NUMBER OF UNITS:

Unit #

Collection Date

Expiration Date

Product Code

Disposition

Notification

(MM/DD/YYYY)

(MM/DD/YYYY)

(Y,N,RN)

 

 

 

 

 

 

 

 

 

1.)

 

 

 

 

 

 

 

 

 

 

 

2.)

 

 

 

 

 

 

 

 

 

 

 

3.)

 

 

 

 

 

 

 

 

 

 

 

4.)

 

 

 

 

 

 

 

 

 

 

 

5.)

 

 

 

 

 

 

 

 

 

 

 

6.)

 

 

 

 

 

 

 

 

 

 

 

7.)

 

 

 

 

 

 

 

 

 

 

 

8.)

 

 

 

 

 

 

 

 

 

 

 

9.)

 

 

 

 

 

 

 

 

 

 

 

10.)

 

 

 

 

 

 

 

 

 

 

 

11.)

 

 

 

 

 

 

 

 

 

 

 

12.)

 

 

 

 

 

 

 

 

 

 

 

13.)

 

 

 

 

 

 

 

 

 

 

 

14.)

 

 

 

 

 

 

 

 

 

 

 

15.)

 

 

 

 

 

 

 

 

 

 

 

16.)

 

 

 

 

 

 

 

 

 

 

 

17.)

 

 

 

 

 

 

 

 

 

 

 

18.)

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 3486 (10/12)

Page 5 of 8

 

Biological Product Deviation Report

C2. NON-BLOOD PRODUCTS

TOTAL NUMBER OF LOTS:

Lot #

Expiration Date

Product Type

Product Code

Disposition

Notification

(MM/DD/YYYY)

(Y,N)

 

 

 

 

 

 

 

 

 

 

1.)

 

 

 

 

 

 

 

 

 

 

 

2.)

 

 

 

 

 

 

 

 

 

 

 

3.)

 

 

 

 

 

 

 

 

 

 

 

4.)

 

 

 

 

 

 

 

 

 

 

 

5.)

 

 

 

 

 

 

 

 

 

 

 

6.)

 

 

 

 

 

 

 

 

 

 

 

7.)

 

 

 

 

 

 

 

 

 

 

 

8.)

 

 

 

 

 

 

 

 

 

 

 

9.)

 

 

 

 

 

 

 

 

 

 

 

10.)

 

 

 

 

 

 

 

 

 

 

 

11.)

 

 

 

 

 

 

 

 

 

 

 

12.)

 

 

 

 

 

 

 

 

 

 

 

13.)

 

 

 

 

 

 

 

 

 

 

 

14.)

 

 

 

 

 

 

 

 

 

 

 

15.)

 

 

 

 

 

 

 

 

 

 

 

16.)

 

 

 

 

 

 

 

 

 

 

 

17.)

 

 

 

 

 

 

 

 

 

 

 

18.)

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 3486 (10/12)

Page 6 of 8

 

Biological Product Deviation Report

D.ADDITIONAL COMMENTS

FORM FDA 3486 (10/12)

Page 7 of 8

 

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

"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."

FORM FDA 3486 (10/12)

Page 8 of 8

 

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