FDA Form 3911

FDA Form 3911 is the FDA notification form used by trading partners to report illegitimate product under DSCSA. The form captures the product, incident, company, and contact details FDA needs for an illegitimate product notification. For FDA instructions and submission context, see Notify FDA of Illegitimate Products.

Use the Form 3911 workflow to create, notify, update, and close FDA Form 3911 tickets tied to suspect or illegitimate product investigations. The workflow lives alongside the Tracing Module so investigation records, trading partner notifications, notes, attachments, and the FDA-assigned 3911 number stay in one place.

For electronic tracing requests and responses, see the Tracing Module article. This article covers the Form 3911 ticket lifecycle and the field reference used for the example investigation scenario.

Form 3911 Workflow Overview #

At a high level, the Form 3911 workflow is as follows:

1. Go to Form 3911 and select New Ticket.
2. Complete the applicable form fields using the investigation and product data.
3. Open the created 3911 ticket and select Notify trading partners.
4. Select the relevant contact or trading partner and submit the notification.
5. Confirm the selected trading partner receives the 3911 notification email.
6. Add the 3911 number assigned by FDA when it is available.
7. Add notes and supporting file attachments as needed.
8. Mark the ticket as Closed when follow-up is complete.

Expected Ticket Updates #

Action	Expected result
Create a new Form 3911 ticket	A ticket is created.
Notify trading partners	The ticket is updated with the receiving parties indicated.
Confirm partner notification	The selected contact receives an email notification with the 3911 notification.
Add the FDA-assigned 3911 number	The ticket is updated with the 3911 number.
Add a note and file attachment	The ticket is updated with the note and file attachment.
Close the ticket	The ticket is updated with a Closed status.

Form 3911 Field Reference #

The example data below is fictional and can be replaced with the details from the active investigation.

Field	Subfield	Example data
Type of Report	—	Initial notification
Incident Number	—	3911-2026-0147
Geographic Location of Incident	Address	745 Meridian Park Drive
Geographic Location of Incident	City	Millhaven
Geographic Location of Incident	State/Province/Region	NJ
Geographic Location of Incident	ZIP/Postal Code	08999
Date of Initial Notification to FDA	—	2026-02-28
Date Company Determined Product Was Illegitimate	—	2026-02-27
Classification of Notification	—	Counterfeit
Name of Product as It Appears on Label	—	Lumintrava
Primary Ingredient(s)	—	Nexomab alfa
Drug Use	—	Human use
Drug Description	—	Finished prescription drug
Strength of Drug	—	40 mg
Dosage Form	—	Injection solution
Quantity of Drug (Number and Unit)	—	1 single-dose vial
NDC Number	—	99999-3911-01
Serial Number	—	SN3911X8F2047
Lot Number(s)	—	MVX2407A
Expiration Date(s)	—	2028-09-30
Description of Event/Issue	—	Simulated exercise for suspected counterfeit secondary packaging. No commercial product is involved.
Description of why notification is no longer necessary	—	Simulated exercise closed after internal review.
Alternative Submission Method(s)	—	None
Company Name & Address	Name	Aster Vale Therapeutics, Inc.
Company Name & Address	Address 1	1000 Meridian Research Way, Suite 400
Company Name & Address	Address 2	Leave blank.
Company Name & Address	City	Millhaven
Company Name & Address	State/Province/Region	NJ
Company Name & Address	Country	United States of America
Company Name & Address	ZIP/Postal Code	08999
Company Category	—	Manufacturer
Unique Facility Identifier	—	9993911001
Contact Information	Name	Jordan Sample
Contact Information	Telephone Number	555-010-3911
Contact Information	Email Address	test-3911@example.invalid

Notes and Attachments #

Use ticket notes and file attachments to preserve supporting details for the investigation. After the FDA-assigned 3911 number and all supporting records are captured, close the ticket to complete the workflow.

Last updated July 3, 2026