Get Form 3331a

This guide provides a clear and supportive overview of how to complete the Form 3331a online for submitting Field Alert Reports. Follow the step-by-step instructions to ensure accurate and efficient submission.

Follow the steps to accurately fill out the Form 3331a online.

1. Click ‘Get Form’ button to obtain the form and open it in your online editor.
2. Select the FDA Office of Regulatory Affairs (ORA) district office responsible for the facility where the problem occurred. For foreign facilities, choose the district office responsible for the location of your authorized U.S. agent.
3. Verify that the name and address of the district office appear at the top of the form in the ‘To’ section.
4. Indicate the ‘Type of Report’ by checking the appropriate box—whether it is an initial, follow-up, or final report.
5. Enter the firm name and address of the facility where the problem occurred in Field 1.
6. Provide the DUNS and FEI number of the facility listed in Field 1.
7. Select the appropriate NDA or ANDA number in Field 3, including the right prefix for CBER-regulated drug products.
8. Enter the NDC number of the drug product in Field 4.
9. Fill out the generic name and trade/brand name of the drug product in Fields 5 and 6, respectively.
10. Complete Fields 7a and 7b by providing the dosage form and dosage strength, including the package size.
11. List the lot number and expiration date in Field 8, separating multiple entries with semicolons.
12. Enter the date when the problem was first discovered in Field 9.
13. Describe how the problem was discovered in Field 10.
14. Provide details about the nature of the problem in Field 11.
15. Explain the root causes of the problem in Field 12.
16. Describe any corrective actions taken to prevent recurrence in Field 13.
17. Use Field 14 for additional remarks or information relevant to the FAR.
18. Complete the ‘Reporting Establishment’ section with required contact details.
19. Save the completed form to your computer before you click the 'Submit by Email' button. Ensure you create both an editable and a read-only version.
20. After saving, click the 'Submit by Email' button to open a new email for submission. Attach the read-only PDF copy of the form and any other relevant documents.

Take action now by filling out the Form 3331a online for a smooth submission process.