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  5. Instructions for Using the eBPDR System
  1. Report a Problem to the Center for Biologics Evaluation & Research

Instructions for Using the eBPDR System

For use by manufacturers to report biological product deviations (BPD) to the Center for Biologics Evaluation and Research (CBER) 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 manufactures of human cells, tissue and cellular and tissue-based products (HCT/Ps) to report HCT/P deviations in accordance with 21 CFR 1271.350(b). The eBPDR system should not be used for submitting BPD reports to the Center for Drug Evaluation and Research.


General Instructions

Menu

My Establishments

My Reports

Reporting Establishment Information

Deviation Establishment Information

Biological Product Deviation (BPD) Information

Collection of BPD Additional Information (AI) for Recall Classification Purposes


Problems?


General Instructions

FDA’s Industry Systems (FIS)

An electronic portal called “FDA Industry Systems” (FIS) provides systems for electronic submissions to FDA. Users can submit information by completing the electronic form while the user is logged into the system.  

FDA’s Unified Registration Listing Systems (FURLS)

FDA’s Unified Registration Listing Systems (FURLS) is a specific component of the general FIS electronic portal.  Persons with a FURLS Account ID and password for the FIS electronic portal can submit a biological product or HCT/P deviation report electronically.  The FURLS component that is relevant to this document is the CBER Biological Product Deviation Reporting (CBER eBPDR).

  • Complete all sections that apply to your report.
  • Date fields may be entered in mm/dd/yyyy format or by using the calendar icon next to each date field.
  • If you do not know the exact dates, make your best guess.
  • All fields are required, unless identified as optional. The required fields must be completed, or you will not be permitted to move to the next page or submit the form. If you do not complete a required field an error message will appear indicating the field is required.
  • Use theSave & Continue or Previous buttons for on screen navigation. The progress bar, or stepper, is located near the top of each page. This identifies how much of the report has been completed and what is remaining. Color, text and icons are used to indicate when a section is completed or in progress. The stepper can also be used to navigate to any completed section.
  • Navigate within a screen using the mouse or the Tab key.
  • Additional information/definition of a data field is provided via a question mark (“?”) icon next to the field label.
  • The contact person's email address is required to facilitate obtaining additional information regarding the BPD report.
  • Complete a separate report for each BPD. If a BPD involves more than one product, only one report needs to be completed listing all distributed products affected.
  • DO NOT include donor, patient, or employee personal identification information or other confidential information.
  • DO NOT use this system 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 system 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 on the Medwatch web page. Information regarding Vaccine Adverse Experience Reporting for vaccine products is available on our VAERS page .
  • For narrative entries, you may enter up to 3,999 characters (unless specified otherwise). If you enter more than the allowable number of characters, the additional characters will not be saved with your entry.
  • For any narrative entries, you may copy ASCII text information from another document source and paste into the narrative block.
  • Send amended or follow-up 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. Please include the confirmation number of the original report.
  • After logging into the system, you have 30 minutes to enter information and continue onto the next page. After 25 minutes of inactivity, you will get a message, “Your session is going to expire in the next 5 minutes. Please click on OK to extend the current session.”
    • If you click OK, then the session is extended.
    • If you do not take any action, your session expires and the system will display, “Your session has expired. Click here again or contact the FDA Industry Systems Help Desk.”
  • It is highly recommended that you do not use the back and forward buttons on your browser. Unexpected results may occur. Use the buttons on each page for form navigation.
  • To exit the system, click on FURLS Home. On the Online Account Administration page, click on Logout, located at the top right had corner.

Menu

eBPDR Home – navigates to main eBPDR page.
My Establishments – navigates to My Establishments page. You can view/update establishments associated with your account here.
My Reports – navigates to My Reports page. You can view/update BPD-AI and BPD reports associated with your account here.

When navigating between pages, a warning message appears, “WARNING: Are you sure you want to navigate away from this page? You will lose all unsaved data entered during this session. Press OK to continue without saving or press Cancel to remain on this page.”

My Establishments

To electronically submit a BPD report, a user's account must be associated with the establishment(s) for which they are reporting. You can create associations on the My Establishments page. Each establishment listed on this page will also appear in the "Select Your Establishment" drop down list when you select Create Report button on the My Reports page.

  • You will need your establishment identification number and identification number type (e.g. FEI or CLIA) to add the establishment.
  • The reporting establishment is the establishment who had control over the distributed product at the time the BPD 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 by 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.

Registration Number - an 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 the Centers 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.

 To add an establishment

  • Select the Establishment Identification Number Type (CLIA or FEI), and enter the Establishment Identification Number then click the Add Establishments button.
  • A confirmation screen will appear if you have entered a valid Identification Number and Number Type. By clicking the Yes button, you are agreeing that you are a valid representative of this establishment and may legally submit BPD reports for this establishment. Click the No button to cancel your association request and return to the previous page.
  • Repeat this process for each establishment with which you want to request an association.

To remove an establishment

  • If you wish to remove your association with an establishment, click the delete icon (red “X”) on the My Establishments Table.
  • A confirmation screen will appear asking if you are sure you want to remove your association to this establishment. Click OK to remove the establishment or click Cancel to cancel your request.

My Reports

  • The display of reports includes reports for establishments created with your account or created by a subaccount associated with the account.
  • To sort the reports, click on the column header. An arrow icon will display (up or down) to indicate sorting in ascending or descending order.
  • To open a BPD-AI Report or BPD Report for editing, select the pencil icon for the applicable report.
  • To open a BPD-AI Report or BPD Report for viewing, select the eye icon for the applicable report.
  • To print a BPD Report, select the print icon for the applicable report.
  • To delete a BPD Report, select the delete icon for the applicable report. This only applies to unfinished BPD reports.
  • To create another BPD report for the same facility, select the copy icon for the applicable report.

Unfinished Reports

  • BPD Additional Information (AI) Report are used for the collection of BPD AI for recall classification purposes.
    • The BPD-AI Report displays in the Unfinished BPD-AI Reports table until the report is submitted to FDA.
  • The unfinished BPD reports that you have modified with the last 30 days, but not submitted to FDA, will display in the Unfinished BPD Reports table.
    • A BPD report is available for editing up to 30 days after your last modification. This date is reflected in the column “Draft Available Until”. Reports that are not modified with the past 30 days will be removed from the system.
    • Once you submit the report to the FDA, it will no longer display in the Unfinished BPD Reports table. It will display in the BPD Reports Submitted Within the Past 90 days table.

To enter a new report

  • From the Menu bar, select My Reports.
  • Under Unfinished BPD Reports, click Create Report.
  • Select your establishment from the drop-down list and click the Next button.

Submitted Reports

  • BPD reports submitted to the FDA within the last 90 days will display in the BPD Reports Submitted Within the Past 90 days table.
  • A report is available up to 90 days after you submit it. This date is reflected in the column “Submission Date”.
  • Reports are displayed in descending order by submission.
  • Please note that submitted BPD-AI reports are not accessible for viewing after submission to FDA.

Reporting Establishment Information

The establishment information corresponding to the Establishment Identification Number selected is automatically populated. Verify that this information is correct. If an incorrect establishment identification number was entered, click the Previous button to select another establishment. If the establishment identification number is correct, but the information displayed is incorrect, Contact CBER.

  • Enter the following information in the event we need more information or need to contact you:
     
    • Telephone Number - The telephone number of the person who is the point of contact.
    • Point of Contact - Name of the person who is the point of contact for the report.
    • Contact Email Address - The E-mail address of the person who is the point of contact - this must be in the form of a valid email address.
  • Tracking Number - Your establishment's internal tracking number to identify individual reports. This number should 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 numbers should not allow for duplicate numbers.
  • “Please check here if the Deviation did not occur at this Reporting Establishment” - Check this box if the BPD occurred at a contract facility under your control or at another facility under your control such as an auxiliary facility (e.g., donor center, distribution center). After you click continue, the system will prompt you to enter information about the facility where the deviation occurred.

Deviation Establishment Information

If the BPD occurred at an establishment other than the reporting establishment, please enter the Establishment ID Number, ID Type, and then click the Search button.

  • If the system recognizes the establishment, the establishment details will populate automatically. 
  • To change your selection of deviation establishment, enter a different Establishment ID, ID Type, and then click the Search button.
  • If you do not know the Establishment’s FEI (or CLIA if not registered), please contact the facility for this information.

If you enter information on the Deviation Establishment Information page and uncheck the box indicating the deviation did not occur at the reporting establishment, the information on the Deviation Establishment page will be removed.

Biological Product Deviation (BPD) Information

Enter as much information as possible about the deviation

  • Date BPD Occurred - The date the deviation or unexpected event occurred.
  • 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.
  • Date BPD Reported - The date the report is completed. This date is auto-populated with the current date upon creating the report. If you save the report for retrieval and submit at a later date, please update this date accordingly prior to submittal.
  • Type of Product - Check either Blood Product or Non-Blood Product 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, allergenics, in-vitro diagnostics, plasma derivatives, and HCT/Ps
  • BPD Code - Enter the code from the BPD Code listing that best describes the BPD.
    • Select BPD Code: Displays a selectable list of BPD codes and populates the BPD code field with the user's selection. The description of the BPD Code automatically populates.
    • BPD Description: Displays the description of the BPD Code if you manually enter any or all three parts of the BPD Code. If you change the BPD code, the BPD Description will automatically update the description of the BPD code.
    • 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.


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 Control

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 | - | | 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-??-??

Description of Biological Product Deviation (BPD) Information

Description of BPD - Describe the event in detail, including a 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.

  • You may enter a maximum of 3999 characters. As you type, a counter above the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

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.

  • You may enter a maximum of 3999 characters. As you type, a counter above the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.
     
  • Description of Follow-up - Describe the intended short term and long-term follow-up action plans, if applicable. You do not have to implement the corrective action identified at the time of filing this report. You may enter a maximum of 3999 characters. As you type, a counter above the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

Blood Products / Components Information (if you selected blood product)

Blood Products / Components Information page will display if you select Blood Product on the BPD Information page.

  • Total Number of Unit(s) - 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 and the number of components is 3.
  • Total Number of Component(s) / Lot(s) - Enter the total number of components (for blood products) potentially affected by the BPD.
  • Click the button Update Product Grid to update the number of rows that will be completed in the product grid.
  • Enter the component information directly on the Blood Products/Components Information page.
  • You may upload product component information from a Microsoft Excel file (XLS format) into the eBPD report you are preparing. 
  • If the Total Number of Component(s)/Lot(s) is more than 100, please enter the product information for the first 100 and enter remaining component information on the comment page later.  This applies to both manual entry and uploading of component information.

Manual entry on the Blood Products/Components Information Page

  • Enter each component for which you have all the required information.
  • After entering all components, click the Save & Continue button to navigate to the BPD Report Preview page.
  • If you do not have all the required information for a component, click the Save & Continue button and enter as much information as possible in the comments section.
  • Information may only be entered in the comment section if all the product information has not been entered in the product grid.

For each component provide the following:

  • Unit # - donor or 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.
  • Blood Product Code - specific blood product code. Click in the Blood Product Code field and start typing the product code.  The product code will automatically populate as you enter the code. Once the correct code is displayed, click on it. You may also use the link (Blood Product Codes) to display a list of blood products. Use the code YY01 for products for further manufacture, such as recovered plasma. Use the code DB00 for products not listed on the Blood Products Code List and specify the product in the Additional Information Section.
  • Distribution – select from the drop-down list whether the product was distributed in-house or to another facility. DO NOT list any products that were not distributed.
    • Distributed in-house - distributed from the blood bank within a hospital to another department, e.g., emergency room, surgery, nursing floor, etc.
    • Distributed to another facility - 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 or blood components.
  • Disposition - provide the disposition of the product using the drop-down lists
    • 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 - (Explain in Additional Info.) - if other is selected, please explain in Additional Information.
  • Notification – select Yes or No from the drop-down list 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:
The blood bank distributed a unit of RBC's 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: Distributed in-house/Returned and corrected
  • Notification: RN (reverse notification)

The blood center distributed a unit of RBC's 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: Distributed to another facility/Transfused
  • Notification: Yes
     
  • Additional Information - use this section to further explain product information, such as product code, product disposition, or notification.

Blood Product Upload

You may upload product component information from a Microsoft Excel file (XLS format) into the eBPD report you are preparing.  The ability to upload is enabled when no rows are entered on the Blood Product information page.

  • Create the XLS file based on the blood product upload file specifications listed below.
  • Enter your component data into the XLS file and save it as specified below.
  • On the Product Information page, enter the number of units and components.
  • Click on the Update Product Grid button.
  • Click on the radio button to Upload Excel sheet containing your product(s).
  • Click the link on #5 of the on-screen instructions to upload a Product Information file.
  • Click the Browse button to find and select the XLS file containing your component data.
  • Once your file is selected and the file name displays in the “Select the file to upload” field, click the Upload button.
  • If your upload fails, the system will display a message explaining the reason for failure. Click the Cancel button to clear error message. Correct the error(s) in the XLS file and attempt your upload again.
  • If your upload is successful, your information will display on the Blood Products/Components Information page.
  • You may review and edit the uploaded information directly on the Blood Products/Components Information page before continuing with your eBPDR submission. 
  • If you would rather make changes to your upload file and re-upload your data, click the Clear All button to clear all entered components.  Once all data is cleared from the screen, follow the directions again for uploading a file.

Important Note:  This process does not allow uploading of more than 100 product components.  If the Total Number of Component(s)/Lot(s) is more than 100, please upload the information for the first 100 and then enter remaining component information on the comments page after uploading.

Blood Product Upload File Specifications

File Type - The blood product upload file must be created in Microsoft Excel and saved as file type XLS.   Please do not save the file as XLSX, XLSM, CSV, or other file types since they will not upload properly.

Save the upload file as one of these types:

  • Microsoft Office Excel Workbook (.xls)
  • Excel 97-2003 Workbook (.xls)

Data Placement - All data must be entered on the first (left most) sheet of the XLS file.  The sheet name is not important.

Column Names - Row 1 is used to list the column names. Columns must be named (including spaces) and ordered as listed below.  

  • Column A Name: Unit Number
  • Column B Name: Collection Date
  • Column C Name: Expiration Date
  • Column D Name: Blood Product Code
  • Column E Name: Disposition 1
  • Column F Name: Disposition 2
  • Column G Name: Notification
  • Column H Name: Additional Information

Number of Components - You may upload as many components as you identified in the Total Number of Components/Lots field on the BPD Information page up to and including 100.   

If the Total Number of Component(s)/Lot(s) value on the BPD Information page is more than 100, you may upload the product information for the first 100 and enter remaining component information on the comment page later. 

Enter Component Data - Enter component data on your spreadsheet starting in row

1.  Please enter only one component per row.  The table below indicates the allowable data entry values for each column.

Column Name

Allowable Values

Entry
Required?

Unit Number

Up to 20 characters

Yes

Collection Date

Format MM/DD/YYYY (please include slashes)

 

Expiration Date

Format MM/DD/YYYY (please include slashes)

 

Blood Product Code

See Biological Product Deviation Reporting and HCT/P Deviation Reporting - Blood Product Codes for a list of valid blood product codes.

Yes

Disposition 1

Distributed in-house
Distributed to another facility

Yes

Disposition 2

No information
Corrected by consignee
Destroyed by consignee
Expired
Returned and corrected
Returned and destroyed
Sent for further manufacturing
Sent for further manufacturing of non-injectable products only
Transfused
Other (Explain in additional info.)

Yes

Notification

Yes
No
RN

Yes

Additional Information

Up to 500 characters

 

Save the Upload File – Important Note:  After entering component information, save the upload file as one of these types:

After saving, please close the file and close Microsoft Excel before proceeding to upload the file.

Non-Blood Products Information (if you selected non-blood product)

Non-Blood Products Information will display if you selected Non-Blood Product on the BPD Information page.

  • Total Number of Lot(s) - Enter the total number of distributed lots potentially affected by the BPD.
  • Click the button Update Product Grid to update the number of rows that will be completed in the product grid.
  • Enter lot information directly on the Non-Blood Products/Components Information page.
  • You may upload product component information from a Microsoft Excel file (XLS format) into the eBPD report you are preparing. 
  • If the Total Number of Component(s)/Lot(s) is more than 100, please enter the product information for the first 100 and enter remaining lot information on the comment page later.  This applies to both manual entry and uploading of lot information.

Manual Entry - Non-Blood Products/Components Information

  • Enter each lot for which you have all the required information.
  • After entering all lots, click the Continue button to navigate to the BPD Report Preview page.
  • If you do not have all the required information for a lot, click the continue button and enter as much information as possible in the comments section.

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, which may be selected using the drop-down list:
    • 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 because they do not meet the criteria in 21 CFR 1271.10(a).  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).

  • Non-Blood Product Code - specific non-blood product code.  Click in the Non-Blood Product Code field and start typing the product code.  The product code will automatically populate as you enter the code. Once the correct code is displayed, click on it.   You may also use  the link Non-Blood Product Codes to display a list of non-blood products.
  • Disposition - provide the disposition of the product using the drop-down 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 at time of reporting.
    • 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 (Explain in Additional Info.) - if other is selected, please explain in Additional Information.

Disposition 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 you notified a consignee.
  • Additional Information - use this section to further explain product information, such as product code, product disposition, or notification.

Non-Blood Product Upload

You may upload product component information from a Microsoft Excel file (XLS format) into the eBPD report you are preparing.  The ability to upload is enabled when no rows are entered on the Non-Blood Product information page.

  • Create the XLS file based on the Non-blood product upload file specifications listed below.
  • Enter your lot data into the XLS file and save it as specified below.
  • On the Non-Blood Product Information page, enter the number of lots.
  • Click on the Update Product Grid button.
  • Click on the radio button to Upload Excel sheet containing your product(s)
  • Click the link on #5 of the on-screen instructions to upload a Product Information file.
  • Click on the Browse button to find and select the XLS file containing your lot data.
  • Once your file is selected and the file name displays in the “Select the file to upload” field, click the Upload button.
  • If your upload fails, the system will display a message explaining the reason for failure. Click the Cancel button to clear error message. Correct the error(s) in the XLS file and attempt your upload again.
  • If your upload is successful, your information will display on the Non-Blood Products/Components Information page.
  • You may review and edit the uploaded information directly on the Non-Blood Products/Components Information page before continuing with your eBPDR submission. 
  • If you would rather make changes to your upload file and re-upload your data, click the Clear All button to clear all entered lot data.  Once all data is cleared from the screen, follow the direction again for uploading a file.

Important Note:  This process does not allow uploading of more than 100 product lots.  If the Total Number of Component(s)/Lot(s) is more than 100, please upload the information for the first 100 and then enter remaining lot information on the comments page after uploading.

Non-Blood Product Upload File Specifications

File Type - The non-blood product upload file must be created in Microsoft Excel and saved as file type XLS.   Please do not save the file as XLSX, XLSM, CSV, or other file types since they will not upload properly.  

Save the upload file as one of these types:

  • Microsoft Office Excel Workbook (.xls)
  • Excel 97-2003 Workbook (.xls)

Data Placement - All data must be entered on the first (left most) sheet of the XLS file.  The sheet name is not important.

Column Names - Row 1 is used to list the column names. Columns must be named (including spaces) and ordered as listed below.  

  • Column A Name: Lot Number
  • Column B Name: Expiration Date
  • Column C Name: Product Type
  • Column D Name: NonBlood Product Code
  • Column E Name: Disposition
  • Column F Name: Notification
  • Column G Name: Additional Information

Number of Lots - You may upload as many lots as you identified in the Total Number of Components/Lots field on the BPD Information page up to and including 100. 

If the Total Number of Component(s)/Lot(s) value on the BPD Information page is more than 100, you may upload the product information for the first 100 and enter remaining lot information on the comment page later. 

Enter Lot Data - Enter lot data on your spreadsheet starting in row 2.  Please enter only one lot per row.  The table below indicates the allowable data entry values for each column.

Column Name

Allowable Values

Entry
Required?

Lot Number

Up to 20 characters

Yes

Expiration Date

Format MM/DD/YYYY (please include slashes)

 

Product Type

Allergenics
Derivatives
In-Vitro Diagnostics
Therapeutics
Vaccines
351 HCT/Ps
361 HCT/Ps

Yes

NonBlood Product Code

See Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes for a list of valid non-blood product codes.

Yes

Disposition

Destroyed by consignee
Distributed
Expired
Returned and destroyed
Returned and reworked
Sent to distributor
Other (Explain in additional info.)
(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

Yes

Notification

Yes
No

Yes

Additional Information

Up to 500 characters

 

Save the Upload File – Important Note:  After entering lot information, save the upload file as one of these types:

  • Microsoft Office Excel Workbook (.xls) 
  • Excel 97-2003 Workbook (.xls)

After saving, please close the file and close Microsoft Excel before proceeding to upload the file.

Comments Section (blood products)

If you do not have all the required information for a component, enter as much information as possible in the comments section. 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 100 components were potentially affected, enter the product information for the first 100 components and enter the remaining unit numbers in this section. You may copy information to this section from another source in ASCII text.

  • You may enter a maximum of 3,999 characters. As you type, a counter above the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

After entering information in the Comments Section, click the Save & Continue button. Electronic Biological Product Deviation Report Preview page will display.
The following are examples of ways to enter information when multiple units are involved:

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

  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:
    • Comments Section: Additional units - 1235, 1236, 1345, 1844, 2900 and 4344.
  2. Information for 18 components entered on the Blood Products/Components Information Page, additional component information entered in the Comments Section (2 examples):
    • Additional products - Transfused, No Notification - Product Code DB29: 01X1111, 01X0000, 01X2222, 01X3333, 01X4444. Product Code DB56: 01X5555, 01X6666, 01X77777, 01X8888, 01X9999.
    • 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.

Comments Section (non-blood products)


If you do not have all the required information for a lot, enter as much information as possible in the comments section. 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 100 lots were potentially affected, enter the product information for the first 100 lots and enter the remaining lot numbers in this section. You may copy information to this section from another source in ASCII text.

  • You may enter a maximum of 3,999 characters. As you type, a counter above the text field will display the number of allowable characters remaining for entry.
  • Please note if you enter more characters than allowed, the excess characters are removed from the screen automatically and are not saved to the database.

After entering information in the Comments Section, click the Continue button. The Electronic Biological Product Deviation Report Preview page will display.
The following are examples of ways to enter information when multiple lots are involved:

  1. Information for one lot entered, additional lots with same information entered in the Comments Section:
    Additional lots- 1235, 1236, 1345A, 1345B.
  2. Product information entered for 18 lots, additional lot information entered in Comments Section: Additional products - Distributed, No Notification - Product Code GR65: X0111, X0022, X2244, Product Code GS22: S5555, S6666, S7777, Product Code: GS34: T8888, T9999.

BPD Report Preview Page

The Electronic Biological Product Deviation Report Preview page is displayed with all the information entered. Review the information to verify accuracy. Please note that you have 30 days to modify or submit the report to FDA. Reports that you have not edited or submitted after 30 days will be deleted and you will have to re-enter the information in a new BPD report.

  • Edit – An Edit button is present on each section of the Review Page. Click this to navigate to any section and make corrections.
  • Print – Allows users to Print and/or Save a pdf copy of the BPD report prior to submitting. The report will display the pre-confirmation number (designated by P#<confirmation number>) and state, “This Report Has Been Saved but Not Submitted To FDA”.
  • Submit - If all information is correct click the Submit button. If all required information is present, the Electronic Biological Product Deviation Receipt Confirmation will be displayed with the confirmation number. Please refer to the Report Confirmation number listed in the event additional correspondence is needed.

BPD Confirmation Page

  • Print - Allows users to Print and/or Save a pdf copy of the BPD report. The report will display the confirmation number and the date submitted. You may also print the report from the My Reports page in the BPD Reports Submitted to FDA in the Past 90 days table.
  • Back to My Reports – navigates to the My Reports page.

Collection of BPD Additional Information (AI) for Recall Classification Purposes

BPD AI - For use by biological product manufacturers to provide information for recall classification purposes in accordance with 21 CFR, Part 7 Enforcement Policy; Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedure, and Industry Responsibilities. The collection of additional information (BPD-AI) associated with a BPD for the purpose of recall classification will be requested through an e-mail notification to the submitter of the BPD.

If you need assistance, you may e-mail CBER_RecallAlerts@fda.hhs.gov.

 General Instructions for Completing BPD Additional Information (AI) Reports:

  • It is recommended that you print these instructions for reference when completing the BPD AI report.
  • Complete a separate BPD AI report for each BPD AI request that you received an e-mail notification from CBER_RecallAlerts@fda.hhs.gov regarding.
  • Complete all sections that apply to your report and submit to FDA.
  • Only the unit/lot numbers and product codes for which CBER requests more information will appear pre-populated in the BPD AI report. Date fields may be entered in mm/dd/yyyy formats or selected by using the calendar icon next to each date field. If exact dates are not known, make your best guess.
  • If a required field is not entered, a message will display indicating which field must be entered.
  • When required based on your responses, conditionally required fields must be completed or you will not be permitted to proceed to the next screen or submit to FDA.
  • Navigate within a screen using the mouse or the Tab key.
  • Navigate from screen to screen using buttons at the bottom of each page. It is highly recommended that you do not use the back and forward buttons on your browser as unexpected results may occur.
  • Send amended or follow-up information to CBER via e-mail to CBER_RecallAlerts@fda.hhs.gov. Please include the confirmation number or tracking number of the original BPD report.

Accessing an Unfinished BPD AI Report

When additional information is requested, a BPD AI report entry will appear in the My Reports page in the Unfinished BPD-AI Reports table for the user account with access to the BPD report. To open a BPD-AI Report for editing, select the pencil icon for the applicable report.

BPD AI - Updated Product Disposition Screen

Provide the following additional information (BPD-AI) for products distributed to another facility. Verify consignee(s) were notified and if notified, provide dates of distribution and final disposition(s).

  • Verify Consignee Notified - Use the drop-down pick list to verify ‘Yes' or ‘No' as to whether consignee(s) were notified. Select ‘RN' for reverse notification if a consignee notified you of the deviation.
    • A value of ‘Yes', ‘No', or ‘RN' must be selected for each product.
    • If ‘No' or ‘RN' is selected for all products, click Save & Continue.
    • If ‘Yes' is selected for one or more products, please continue completing the screen.
  • Date Distributed - Provide the distribution date for each row. Entry is required when Verify Consignee Notified equals ‘Yes'. The Distribution Date is the date the product was distributed 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.
  • Final Disposition - Select the final disposition for each product. Entry is required when Verify Consignee Notified equals ‘Yes'. Final Disposition values are:
    • ‘Transfused' - product distributed and transfused to a patient.
    • ‘Destroyed by Consignee' - product distributed and destroyed by consignee.
    • ‘Returned and Destroyed' - product distributed, returned to manufacturer and destroyed.
    • ‘Corrected by Consignee' - product distributed and deviation corrected by consignee.
    • ‘Returned and Corrected' - product distributed, returned to manufacturer and deviation corrected.
    • ‘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.
    • ‘Culled from Manufacturing to be destroyed by Consignee' - product distributed and is to be destroyed by consignee.
    • ‘Destroyed during Manufacturing' - product distributed and destroyed by consignee during manufacture.
    • ‘In-house distribution' (IH) - products distributed between facilities with the same license numbers such as ARC to ARC are not considered distributed for recall classification purposes unless the product is further distributed outside the ARC. Note: In-house distribution (IH) is not considered distributed for the purposes of recall classification.
    • ‘No Information' - product distributed, information regarding final disposition not available at time of reporting.
    • ‘Other' - if other is selected, provide further details in the comments field.
  • Final Disposition values for Non-Blood Products are:
    • Transplanted or Infused - (351 or 361 HCT/P) distributed to another facility/transplanted or infused.
    • Destroyed by Consignee - Product distributed and destroyed by consignee
    • Returned and Destroyed - Product distributed, returned to manufacturer and destroyed.
    • Returned and Corrected - Product distributed, returned to manufacturer and corrected.
    • In-House Distribution (IH) - Product remains within your control, or within same facility.
    • No Information - Product distributed, information regarding final disposition not available at time of reporting.
    • Other - If other is selected, provided further details in the comments field.
  • Product Information Comments - Entry is required if "Other" is selected as a final disposition.
  • If you chose a non-specific product code on your BPDR (e.g., DB00), provide the name of the product(s) in the Comments field. You may skip this step if you included this information on your BPDR.
  • Provide Total Quantity Distributed.

BPD AI - Notification Method Screen

Provide method(s) and date(s) of consignee notification. If your method of notification is not one of the available choices, select "Other" and describe the notification method in the Comments field.

  • Initial Notification #1 - Entry of Initial Notification (#1) Method and Date are required.
  • Initial Notification #2 - Provide a second initial notification method and date if needed.
  • Further Notifications - Provide further notification method(s) and date(s) if needed.
  • Notification Comments - Entry is required if "Other" is selected as a notification method.
  • Recall Completion Date - Provide the recall completion date. Recall Completion Date is the latest date of consignee notification.

BPD AI - Distribution Pattern Information Screen

  • Provide distribution pattern for enabled rows. Entry of Distribution Pattern is required for each enabled row.
    • You may select a value for each enabled row.
    • To apply the same value to multiple rows, select a value, select the rows, click “Apply to Selected Rows”.
    • To apply the same value to all rows: select a value, click “Apply to All Rows”.
    • To clear entered values from multiple rows, select the rows and click “Clear Selected Rows”.

Provide counts related to the distribution pattern.

  • Domestic Consignees (total) - Enter the number of Domestic Consignees (located within U.S). Enter zero if appropriate. Entry is required.
  • Foreign Consignees (total) - Enter the number of Foreign Consignees (located outside U.S). Enter zero if appropriate. Entry is required.
  • # of Consignees Responding to Notification (total) - Enter the number of consignees responding to notification. Enter zero if appropriate; entry is required.

Note: The sum of Domestic and Foreign Consignee totals must equal 1 or more.

  • # of Distributors - Enter the number of consignees that are Distributors. (optional)
  • # of Manufacturers - Enter the number of consignees that are Manufacturers. (optional)
  • # of Medical Facilities - Enter the number of consignees that are Medical Facilities. (optional)
  • # of Department of Defense - Enter the number of Department of Defense consignees. (optional)
  • # of Veterans Admin - Enter the number of Veterans Administration consignees. (optional)
  • # of Other U.S. Federal Government. (optional)

Provide comments

  • Distribution Pattern Comments - If you selected the distribution pattern value "Multiple U.S. States" or "Multiple Countries", provide the specific distribution pattern for each lot in the Comments field. Not applicable for HCT/P or blood products.

BPD AI - Industry Recall Contacts Screen

Provide contact information for the Recalling Firm's Most Responsible Individual and Recall Contact.

Most Responsible Individual

  • Official's Name
  • Title (optional)
  • Firm Name
  • Telephone [Country Code, Area Code, Number, Ext.] (optional)
  • Fax [Country Code, Area Code, Number, Ext.] (optional)
  • Email Address
  • Address Line 1
  • Address Line 2 (optional)
  • Country
  • Postal Code (required only for US and Canada)
  • City
  • State/Province (required only for US and Canada)

Recall Contact

To automatically populate Recall Contact information with the information entered for the Most Responsible Individual, click the Auto-Populate from Responsible Individual button.

  • Official's Name
  • Title (optional)
  • Firm Name
  • Telephone [Country Code, Area Code, Number, Ext.] (optional)
  • Fax [Country Code, Area Code, Number, Ext.] (optional)
  • Email Address
  • Address Line 1
  • Address Line 2 (optional)
  • Country
  • Postal Code (required only for US and Canada)
  • City
  • State/Province (required only for US and Canada)
     

BPD AI - Preview Report Screen

Review the information on the Preview Report screen for accuracy.

  • If any information is inaccurate, please navigate to the appropriate screen, make corrections, and then Submit the report.
  • If all information appears correct and complete, submit the BPD AI report by clicking the Submit button.
    • Once submitted, BPD-AI Reports are not accessible.

Buttons - BPD AI - Preview Report Screen

  • Edit - Allows users to navigate to any previous section and make corrections.
  • Edit Another BPD AI Report - navigates to the My Reports page.
  • Print - Allows users to Print and/or SAVE a pdf copy of the BPD-AI Report prior to submitting.
  • Submit - Provides users a warning that they are about to submit a report to the FDA. If you haven’t printed your report, please click Cancel and print your report. Once submitted, you will not be able to access your AI Report. 
    • Submits the report to FDA and navigates to the Confirmation Page where users are provided a Confirmation Number for their records and for future communication with FDA.

Problems?

Biological Product Deviation Reporting (BPDR) CBER Contact Information

If for any reason you are unable to utilize the online system, you may mail your Form FDA 3486 to FDA. If you need the form, you may download it from: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM061463.pdf.
After downloading the form, complete it by following the instructions, save it, print it and send it to the appropriate address:
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
Building 71, Room 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

If you need assistance with the BPD AI Reports (for recall classification purposes), you may contact CBER at 240-402-8953 or by email at CBER_RecallAlerts@fda.hhs.gov.