About FDA

Instructions for using the Form FDA 3331 Automated

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Field Alert Reports – Automated Submission of Field Alert Reports

For those who decide to participate in the voluntary automated pilot program, please follow the instructions below.
Instructions for use of the Form FDA 3331 Automated form
  1. Download the form and save form from link below.
  2. Open the saved file and complete the form (detailed instructions below)
  3. Save the completed form, re-open and click on the submit button located at the bottom of page 3 of Form FDA Automated
  4. Attach a signed copy of the Adobe PDF form to the e-mail which appears
  5. Send the two copies of the form (XML equivalent and signed PDF) using your desktop e-mail application. See also the automated form link and detailed instructions, below.

Form FDA 3331a Automated

Form FDA 3331 Automated Form Detailed Instructions

Form FDA 3331 Automated Frequently asked questions


For additional help, participants are encouraged to contact regional Office of Regulatory Affairs district offices, addresses located on page 2 of the Form FDA 3331 Automated or their Drug Field Alert Monitor at: http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm

For those who choose not to participate, use the traditional form link below:

Additional Instructions for firms to complete Form FDA 3331-Automated on Desktop e-mail applications
The Adobe submit feature is compatible with Web-based e-mail service such as Hotmail, Gmail and Yahoo mail.
Firm’s Instructions:
Note: Initial notifications of potential deviations and subsequent communications between the field alert coordinator (in the jurisdictional FDA District Office where the facility or foreign firm’s authorized official are located), and the firm are not waived, suspended or modified for the purposes of this pilot.
  1. Ensure that you have Adobe Reader version 9 or higher installed on your desktop.
  2. Download a copy of the automated form Form FDA 3331 Automated (3331A) at http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm and complete data entry of field alert information according to the instructions on page (4) of the form.
  3. Once data entry of the form is completed, the Adobe PDF file should be saved, printed and signed according to your internal standard operating procedures.
  4. After completion of signature step, use Adobe Readers (version 9 or higher) to re-open the file used in the preparation of the signed field alert.
  5. After re-opening form, go to page (2) of the completed form, and verify correct Office of Regulatory Affairs checkbox has been checked.
  6. On page (3) of the form, scroll to bottom of page and click on the “submit" button.
  7. Upon hitting “submit” button, your local e-mail compatible client application will open and the email appears which contains the corresponding xml equivalent attachment and the selected district office.
  8. Verify the correctly designated Office of Regulatory Affairs District Office has been added to the “TO” section of your email. Adobe Reader automatically adds CDER as the “CC” recipient. Note: Page 2 check-box selection allows for only one jurisdictional office to be designated as the recipient of your Form 3331 Automated. Firm’s may manually add other district offices to the “TO” line.
  9. Attach your signed PDF version of the field alert to the body of the email.
  10. Ensure your email notification contains two attachments (1) the original signed version from step (9) and (2) the xml equivalent of the text version before sending to the Regional ORA District Office.
  11. If you are unable to utilize the Adobe Reader submit button feature, contact your IT administrator first to ensure that the form is being used in Adobe Reader or Adobe Acrobat version 9 or higher.
  12. Additional details such as the Q&A can be found at PILOT- Form FDA 3331-Automated Pilot Program


Page Last Updated: 09/09/2015
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