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  5. General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
  1. Report a Problem to the Center for Biologics Evaluation & Research

General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486

For use by manufacturers to report biological product deviations (BPD) to the Food and Drug Administration that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also, for use by manufacturers of human cells, tissues and cellular and tissue-based product (HCT/Ps) to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

General Instructions:

  • Complete all sections that apply to your report.
  • If you do not know the exact dates, make your best guess.
  • Complete a separate report for each BPD. If a BPD involves more than one product, only one form needs to be completed listing all distributed products potentially affected.
  • Only submit completed pages of the report. Do not submit blank pages (e.g., 2, 3, 4 and 7) if additional space is not needed.
  • DO NOT include donor, patient, or employee personal identification information or other confidential information.
  • DO NOT use this form to report fatalities that occur as a result of collection or transfusion of blood or blood components. Fatalities must be reported in accordance with 21 CFR 606.170.
  • DO NOT use this form to report Adverse Experiences related to biological products other than blood or blood components or HCT/Ps. Adverse Experiences must be reported in accordance with 21 CFR 600.80 and, for HCT/Ps, 21 CFR 1271.350(a). Information regarding Adverse Experience Reporting is available at www.fda.gov/medwatch/. Information regarding Vaccine Adverse Experience Reporting for vaccine products is available on our VAERS page.
  • Send amended or follow-up reports or information to CBER via e-mail to bp_deviations@fda.hhs.gov. For amended or follow-up information to an HCT/P Deviation report, send an email to hctp_deviations@fda.hhs.gov. When submitting the amended or follow-up report please identify the report as an amended or follow-up report and identify the changes and/or the additional information. Please include the establishment identification number, tracking number, first listed unit or lot number, and the date the report was submitted.
  • For information regarding submission of BPD reports to CDER, please contact CDERDQRSREPORTS@fda.hhs.gov.

A. Facility Information

The reporting establishment is the establishment who had control over the distributed product at the time the occurred.

For example:

  • A BPD that occurs at a Source Plasma collection center may be reported by the corporate office. However, the reporting establishment identification of the Source Plasma collection center should be entered as the reporting establishment.
  • A BPD that occurs at an auxiliary facility (e.g., donor center, distribution center) operating under a blood bank or blood center should be reported by the blood bank or blood center as the reporting establishment.
  • A BPD that occurs at one of several locations of a licensed establishment, may be reported the headquarters location. However, the reporting establishment identification of the location who had control over the product should be entered as the reporting establishment.
  • A BPD that occurs at a contract manufacturing site (e.g., test laboratory, filling facility), should be reported by the license holder of the product.
  • An HCT/P deviation that occurs at an establishment that makes the HCT/P available for distribution or in a facility that is under contract agreement or other arrangement should be reported by the establishment who determined that the HCT/P met all release criteria and made the HCT/P available for distribution.

1. Reporting Establishment Information

Enter the Reporting Establishment's name and address.
Enter the following information in the event we need more information or need to contact you:
Point of Contact: Name of the person who is the point of contact for the report.
Telephone: Enter the telephone number of the person who is the point of contact.
E-mail: Enter the e-mail address of the person who is the point of contact.

2. Reporting Establishment Identification Number

You must enter a valid registration number or CLIA number.

Registration Number - FDA Establishment Identifier (FEI) assigned to your facility.   To obtain your FEI number, please use the link to FDA’s FEI Search Portal at https://www.accessdata.fda.gov/scripts/feiportal. This portal will allow you to look up your own FEI number(s) and obtain your registration information.  There is no charge to create an account. If you have difficulty accessing your information via the portal, you may contact the registration staff below to obtain your firm’s information.

CBER (Blood Establishments): bloodregis@fda.hhs.gov
CBER (Human Tissue): tissuereg@fda.hhs.gov
CDER (Drugs): edrls@fda.hhs.gov
CDRH: (Devices): device.reg@fda.hhs.gov

CLIA Number - a 10-character number that is assigned by Center for Medicare and Medicaid Services (CMS) to facilities who are eligible for Medicare reimbursement. Only provide this number if you do not have a registration number. Transfusion services which are part of a facility that is certified under the Clinical Laboratory Improvement Amendments (CLIA) and which are engaged in compatibility testing and transfusion of blood and blood components, but which neither routinely collect nor process blood and blood components are exempt from registration with FDA [21 CFR 607.65(f)].For a valid CLIA number contact your CLIA State Survey Agency.

3. If the BPD occurred somewhere other than the above facility, please complete this Section and Section A4, otherwise continue on to Section B1.

Enter the Establishment's name and address.

4. Establishment Identification Number: Enter the Establishment Identification - either Registration number or CLIA number.

B. Biological Product Deviation (BPD) Information

1. Establishment Tracking Number - Your establishment's internal tracking number to identify individual reports. This number can consist of no more than 25 numbers and/or characters. The tracking number should not be your establishment identification number. It should be a unique identifier for each report. Your system of assigning tracking number should not allow for duplicate numbers.
2. Date BPD Occurred - The date the deviation or unexpected event occurred. Please enter using the format mm/dd/yyyy.
3. Date BPD Discovered - The date the deviation or unexpected event was discovered. The date discovered is the date you acquire information reasonably suggesting that a reportable event has occurred. If the event occurred at your contractor, the date of discovery is when the contractor learns about the deviation or unexpected event. Please enter using the format mm/dd/yyyy.
4. Date BPD Reported - The date the report is completed. Please enter using the format mm/dd/yyyy.
5. Description of BPD - Describe the event in detail, including description of what happened and a summary of all relevant information (e.g., labeling, test results, reason for donor deferral, etc.). Do not include any confidential information, such as patient, donor, or employee names. Use page 2 for additional space.
6. Description of Contributing Factors or Root Cause - Describe all contributing factors or root causes of the deviation or unexpected event. Please indicate, if after the investigation, a root cause cannot be determined. Use page 3 for additional space.
7. Follow-up - Describe the intended short term and long-term follow-up action plans, if applicable. You do not have to implement the corrective actions identified at the time of filing this report. Use page 4 for additional space.
8. Please Enter the 6-character BPD Code: Enter the code from the BPD Code Listing that best describes the BPD.

  • Use the Blood Deviation Codes for the BPD's involving blood products.
  • Use the Non-Blood Deviation Codes for the BPD's involving non-blood products.
  • Use the HCT/P deviation codes for the deviations involving HCT/Ps.

The BPD Code is made up of three levels.

The first level (XX) identifies the system affected in which there was a breakdown or failure, which resulted in the distribution of an unsuitable product. Use the appropriate guidance document for determining the system affected.
BPD Code     |   XX   | - |         | - |         |


Summary of Product Codes by Type of Product

For blood products the systems include:

For non-blood products the systems include:

For HCT/Ps the systems include:

DS - Donor Screening

IM - Incoming Material Specifications

DE - Donor Eligibility

DD - Donor Deferral

PC - Process Controls

DS - Donor Screening

BC - Blood Collection

TE - Testing

DT - Donor Testing

CP - Component Preparation

LA - Labeling

FA - Facilities

VT - Transfusion-Transmitted Infection Testing

PS - Product Specifications

EC - Environmental Controls and Monitoring

RT - Routine Testing

QC - Quality Control and Distribution

EQ - Equipment

LA - Labeling

 

SR - Supplies and Reagents

QC - Quality Control and Distribution

 

RE - Recovery

 

 

PC - Processing and Process Controls

 

 

LC - Labeling Controls

 

 

ST - Storage

 

 

SD - Receipt, Pre-Distribution, Shipment and Distribution

The second level (YY) of the code is a subset of the system affected. The third level (ZZ) contains more detailed information regarding the BPD. Select the code that most closely describes the deviation or unexpected event (see list of Deviation Codes). If you cannot determine the appropriate code, enter question marks. For example ??-??-?? or LA-??-??

BPD Code     |         | - |   YY   | - |   ZZ   |

C. Unit / Product Information

Check the type of product: Check either Blood or Non-Blood to identify the type of product potentially affected by the BPD.

Blood Product - includes products manufactured by blood and plasma establishments, such as whole blood, red blood cells, fresh frozen plasma, platelets, and plasma for further manufacture and Source Plasma.

Non-Blood Product - includes products manufactured by a facility other than blood. establishments, such as vaccines, therapeutics, allergenics, in-vitro diagnostics, plasma derivatives, and HCT/Ps.

C1. Blood Products / Components

Total Number of Units: Enter the total number of units. For example, if one unit of whole blood was manufactured into Red Blood Cells, Fresh Frozen Plasma and Platelets, the total number of units is 1.

For each component provide the following:

Unit # - lot number relating the unit to the donor.

Collection date - the date the unit was collected. If the collection date is not known, leave this field blank.

Expiration date - the date the component expires. If the expiration date is not applicable (e.g., for Recovered Plasma), leave this field blank.

Product Code - use the list of specific blood product codes (Blood Product Codes). Use the code YY01 for products for further manufacture, such as recovered plasma. Use the code DB00 for products not listed on the Blood Product Codes list and specify the product in the comments section.

Disposition - provide the disposition of the product using the following list - DO NOT list any products that were not distributed. Valid dispositions are:

Specify if the unit was distributed:

In-house (IH) - distributed from the blood bank within a hospital to another department, e.g., emergency room, surgery, nursing floor, etc.

To another facility (AF) - distributed from a blood center to a hospital, from one hospital to another, or from a blood or plasma establishment to a manufacturer of biological products other than blood and blood components.

Valid dispositions are:

  • No information - product distributed, information regarding final disposition not available at time of reporting.
  • Corrected by consignee - product distributed and deviation corrected by consignee.
  • Destroyed by consignee - product distributed and destroyed by consignee.
  • Expired - product distributed and is now expired, no other information available.
  • Returned and corrected - product distributed, returned to manufacturer and deviation corrected.
  • Returned and destroyed - product distributed, returned to manufacturer and destroyed.
  • Sent for further manufacturing - product distributed for further manufacture.
  • Sent for further manufacturing of non-injectable products only - product distributed for further manufacture into non-injectable products only.
  • Transfused - product distributed and transfused to a patient.
  • Other - if other is selected, please explain in Additional Comments.

Notification - provide either yes or no to identify whether you notified a consignee. If the consignee notified you of the deviation or unexpected event, select RN for reverse notification.

The following are examples of how to report the disposition and notification information:

  1. A unit of RBC's is distributed from the blood bank to the nursing floor. Prior to transfusion the nurse discovers a discrepancy in labeling. The nurse returns the unit to the blood bank and the blood bank corrects the label. The unit is reissued and transfused.

Disposition: IH, Returned and corrected     -     Notification: RN (reverse notification)

  1. A unit of RBC's is distributed from a blood center to a hospital. The blood center discovers a deviation in testing the unit and notifies the hospital to return the unit. The unit was transfused prior to notification from the blood center.

Disposition: AF, Transfused     -     Notification: Y (yes)

D. Additional Comments - use this section to further explain any missing information or product information such as product code, product disposition, or notification. If multiple units have the same information (i.e., collection date, expiration date, product, disposition and notification) enter the information for the first unit number and list the additional unit numbers in this section. If more than 18 units were potentially affected, enter the product information for the first 18 units and enter the remaining unit numbers in this section.

The following are examples of ways to enter information when multiple units are involved:

Additional Comments page: Additional units - 1235, 1236, 1345, 1844, 2900 and 4344

  1. Information for one component (unit number 1234) entered on the Blood Products/Components Information Page and there are additional units with the same information.
  2. Information for 18 components entered on the Blood Products/Components Information Page, additional component information entered on the Additional Comments page (2 examples).
    1. Additional products - Transfused, No Notification - Product Code DB29: 01X1111, 01X0000, 01X2222, 01X3333, 01X4444. Product Code DB56: 01X5555, 01X6666, 01X77777, 01X8888, 01X9999.
    2. Additional products - Notification: Yes - 25 DB29 Distributed; 6 DB56 Distributed; 1 DB00 (pediatric aliquot) Distributed; 1 DB01 Distributed; 1 DB05 Distributed; 1 DB45 Transfused; 7 DB53 Distributed; 25 YY01 Sent for further manufacturing.

C2. Non-Blood Products

Total Number of Lots: Enter the total number of distributed lots potentially affected by the BPD.

For each lot provide the following:

Lot # - lot number of the product.

Expiration Date - the date the product expires.

Product Type - major category of products:

Allergenics
Derivatives
In-Vitro Diagnostics
Therapeutics (regulated by CDER)
Vaccines
"351" HCT/Ps **
"361" HCT/Ps **
Gene Therapy Products

** "351" HCT/Ps – Licensed human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as biological products under section 351 of the Public Health Service Act and the Food, Drug, and Cosmetic Act. For example, Hematopoietic Progenitor Cell, Cord Blood (HPC-C), Autologous Cultured Chondrocytes, autologous T-Cell immunotherapy products.
** "361" HCT/Ps - Human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act because they meet all the criteria in 21 CFR 1271.10(a).

Product Code- Use the list of specific non-blood product codes (Non-Blood Product Codes)

Disposition - provide the disposition of the product using the following list - DO NOT list any products that were not distributed. Valid dispositions are:

  • Destroyed by consignee - product distributed and destroyed by consignee.
  • Distributed - product distributed, information regarding final disposition not available at time of reporting.
  • Expired - product distributed and is now expired, no other information available.
  • Returned and destroyed - product distributed, returned to manufacturer and destroyed.
  • Returned and reworked - product distributed, returned to manufacturer and reworked according to an appropriate procedure.
  • Sent to distributor - product distributed to a facility outside of your control for further distribution.
  • Other - if other is selected, please explain in Additional Comments

Disposition options for 351 and 361 HCT/Ps include:

  • (361 HCT/P) Distributed In-house/transplanted or infused.
  • (351 or 361 HCT/P) Distributed to another facility/transplanted or infused.
  • (361 HCT/P) Distributed In-house/expired.
  • (361 HCT/P) Distributed to another facility/expired.
  • (361 HCT/P) Distributed In-house/destroyed.
  • (361 HCT/P) Distributed to another facility/destroyed.
  • (361 HCT/P) Distributed In-house/returned.
  • (361 HCT/P) Distributed to another facility/returned.

Notification - provide either yes or no to identify whether consignee was notified.

D. Additional Comments - use this section to further explain any missing information or product information, such as product code, product disposition, or notification. If multiple lots have the same information (i.e., expiration date, product code, disposition and notification) enter the information for the first lot number and list the additional lot numbers in this section. If more than 18 lots were potentially affected, enter the product information for the first 18 units and enter the remaining unit numbers in this section.

The following are examples of ways to enter information when multiple lots are involved:

Additional products - Distributed, No Notification - Product Code GR65: X0111, X0022, X2244, Product Code GS22: S5555, S6666, S7777, Product Code: GS34: T8888, T9999.

  1. Information for one lot entered, additional lots with same information entered in the Comments Section:

Additional lots- 1235, 1236, 1345A, 1345B

  1. Product information entered for 18 lots, additional lot information entered in Comments Section

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 should be sent to:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71-G112
Silver Spring, MD 20993-0002

Biological product deviation reports required by 21 CFR 600.14, involving a therapeutic product regulated by the Center for Drugs Evaluation and Research should be sent to:

Food and Drug Administration,
Center for Drugs Evaluation and Research
Office of Pharmaceutical Quality
Office of Surveillance
Division of Quality, Surveillance Assessment (DQSA)
10903 New Hampshire Ave. Bldg. 75, Rm 6654
Silver Spring, MD 20993-0002

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