FDA 3486A Recall Classification

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

WEB FORM ADDENDUM TO FORM 3486A Revision

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

OMB: 0910-0458

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WEB FORM ADDENDUM TO FORM 3486

COLLECTION OF INFORMATION FOR RECALL CLASSIFICATION



The collection of additional information associated with a BPD for the purpose of recall classification will be requested through an e-mail notification to the submitter of the BPD and a web-based form to provide the information.


E-mail



Subject: BPD confirmation #______, Establishment Tracking #_______

Reporting Establishment ID # _______


Thank you for the electronic submission of the Biologic Product Deviation Report (BPDR) referenced below. The Center for Biologics Evaluation and Research (CBER) has completed initial review of this BPDR. Additional information is necessary to complete our review for possible recall classification purposes.


The web form to provide CBER the additional information is available at

https://www.accessdata .fda.gov/scripts/cber/CFApps/Login/Index.cfm


Access to the form requires the BPDR submitter’s username and password.

Upon login, access the electronic BPDR system (eBPDR) and select “Unfinished Reports.”



FEI <FEI #>


BPD Confirmation # <Confirmation #>


BPD Submitted Date <BPD Received Date>


Establishment Tracking # <Establishment Tracking #>



Thank You,


CBER Recall Coordinator

Food and Drug Administration

Office of Compliance and Biologics Quality



Web Form


FORM 3486A – BPDR SUPPLEMENTAL INFORMATION


Reporting Establishment ID #________


Establishment Tracking #__________


BPD Confirmation # __________


(The above items will be pre-populated by the system.)



1. Distribution Pattern


Provide the States (for products distributed within the United States) and/or the Countries (for products distributed outside the United States) where the products were distributed.




Provide counts related to the distribution pattern.


Consignee

#

Consignee

#

Foreign (total)


Manufacturers


Domestic (total)


Veterans Admin.


Distributors


Dept. of Defense


Medical Facilities


Other



If you distributed products to Canada, a U.S. federal government and/or DoD facility, please provide the consignee name and address in the comments field below.


Comments:



Notes: Selectable list of States and Countries will be displayed. Selections will populate the text field.



2. Notification


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. Provide the Recall Completion date.



mm/dd/yyyy

Initial Notification: Method Date




Further Notifications: Method Date




Method Date


R


ecall Completion Date:


C


omments:






Notes: Allow for up to 2 initial notification and 3 further notification entries.

Method fields will be selected from a pick list.





3. Updated Product Disposition


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


Unit

Number

Product

Code

Date Distributed

Verify Consignee

Notified

Final

Disposition

<prefilled>

<prefilled>

Enter mm/dd/yyyy

<prefilled & Select Value>

<Select Value>


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.


Comments:



Notes: Only products needing additional information will display.

Unit number and Product code will be pre-filled and not editable.

Date Distributed will be editable.

Verify Consignee Notified will be pre-filled and editable.

Final Disposition will be selected from a pick list.

Comments field was previously located in section 6 “Name of Products”



4. Industry Recall Contacts


Provide Official’s Name and Contact Information for the Most Responsible Individual and Recall Contact.

Most Responsible Individual


Official’s Name


Title


Firm Name



Street Address Line 1


Street Address Line 2


City



State/Province Postal Code


Country


T


elephone Facsimile


E-mail


Recall Contact


Official’s Name


Title


Firm Name



Street Address Line 1


Street Address Line 2


City



State/Province Postal Code


Country


T


elephone Facsimile


E-mail


Notes: State/Province and Country will be selected from a pick list.






File Typeapplication/msword
File TitleWEB FORM ADDENDUM TO FORM 3486
AuthorHieronymus
Last Modified ByJonna Capezzuto
File Modified2008-09-26
File Created2008-09-26

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