Free 3486 - Federal

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FDA USE ONLY
Date Received: Date Reviewed: BPD ID:

BIOLOGICAL PRODUCT DEVIATION REPORT
* Indicates required information

BPD No. B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION 1. Establishment Tracking # 2. Date BPD Occurred 3. * Date BPD Discovered 4. * Date BPD Reported

A. FACILITY INFORMATION

1. Reporting Establishment Information
* Reporting Establishment Name

* Street Address Line 1 Street Address Line 2

5. * Description of BPD (use Page 2 for additional space) * City Country * Point of Contact * Telephone # E-mail 6. * Description of Contributing Factors or Root Cause (use Page 3 for additional space) * State * Zip Code

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 Street Address Line 2 * City * Country * State Zip Code 8. * Please Enter the 6 Character BPD Code

C. UNIT / PRODUCT INFORMATION

4. Establishment Identification Number FDA Registration # CLIA # FORM FDA 3486 (4/08)
Form Approved: OMB No. 0910-0458 Expires: 6/30/10 See OMB Statement on Page 8.

Please check the type of product:

Blood Non-Blood

(Continued on Page 5) (Continued on Page 6)

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PSC Graphics (301) 443-1090

EF

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

FORM FDA 3486 (4/08)

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

FORM FDA 3486 (4/08)

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

FORM FDA 3486 (4/08)

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Biological Product Deviation Report
C1. BLOOD PRODUCTS / COMPONENTS

TOTAL NUMBER OF UNITS: Unit #
1.)

Collection Date (MM/DD/YYYY)

Expiration Date (MM/DD/YYYY)

Product Code

Disposition

Notification (Y,N,RN)

2.)

3.)

4.)

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6.)

7.)

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FORM FDA 3486 (4/08)

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Biological Product Deviation Report
C2. NON-BLOOD PRODUCTS

TOTAL NUMBER OF LOTS: Lot #
1.)

Expiration Date (MM/DD/YYYY)

Product Type

Product Code

Disposition

Notification (Y,N)

2.)

3.)

4.)

5.)

6.)

7.)

8.)

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18.)

FORM FDA 3486 (4/08)

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Biological Product Deviation Report
D. ADDITIONAL COMMENTS

FORM FDA 3486 (4/08)

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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, gathering 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 Office of the Chief Information Officer (HFA-250) 5600 Fishers Lane Rockville, MD 20857 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 (4/08)

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