Get Fda 3911 Instructions 2015

This guide provides comprehensive instructions for completing the FDA 3911 form online, ensuring that users of all backgrounds can efficiently notify the FDA about illegitimate drug products. By following these step-by-step instructions, users can navigate the form with confidence.

Follow the steps to complete the FDA 3911 Instructions online

1. Click 'Get Form' button to access the form and open it in your preferred online editor.
2. Indicate the type of report by checking one of the three options: Initial Notification, Follow-up Notification, or Request for Termination.
3. Record the incident number, which is assigned by the FDA upon receipt of the initial notification.
4. Enter the date of initial notification using the calendar function or in MM/DD/YYYY format.
5. For manufacturers, indicate when the product was determined to be illegitimate or at high risk of illegitimacy.
6. Select the classification of the illegitimate product, such as Counterfeit, Diverted, Stolen, Intentional adulteration, Unfit for distribution, or Fraudulent transaction.
7. Provide the name of the product as it appears on its label.
8. List the active pharmaceutical or biological ingredients, if known, that are not already mentioned.
9. Choose the approved drug use, specifying either Human use or Other.
10. Select the most specific description for the illegitimate product, which may include options like Finished prescription drug or Vaccine.
11. Provide the strength of the drug, including the unit of measure.
12. Choose the dosage form from the provided list, including options such as Tablet, Capsule, or Injectable.
13. Enter the quantity of the product involved, specifying both number and unit of measure.
14. If known, provide the National Drug Code (NDC) number associated with the product.
15. Include the serial number related to the product, if available.
16. List any relevant lot numbers for the product, separating multiple entries with a comma.
17. Describe the event or issue that prompted the notification, including any pertinent details about the product's journey in the supply chain.
18. If applicable, explain why the notification is no longer necessary, including any corrective actions taken.
19. Indicate any other reporting mechanisms that were used in relation to this notification, checking applicable boxes.
20. Provide the company name and complete address responsible for the notification.
21. Select the company category that describes the entity making the notification.
22. Enter the unique facility identifier, which should be a D-U-N-S number; leave blank if none is available.
23. Provide contact information for a person within the company who can be reached for follow-up.
24. Review all entries carefully for accuracy before proceeding to save, download, print, or share the completed form.

Start completing your FDA 3911 Instructions online today for effective communication with the FDA.