FORM FDA 3911 Instructional Supplement. Instructions for Completion of Form FDA 3911Drug Notification - fda-2025

1. Click ‘Get Form’ to open it in the editor.
2. Begin by selecting the type of report you are submitting: Initial Notification, Follow-up Notification, or Request for Termination. Check the appropriate box.
3. Enter the Incident Number assigned by the FDA upon initial notification receipt. This is crucial for future correspondence.
4. Input the Date of Initial Notification using the calendar function or in MM/DD/YYYY format.
5. For manufacturers, indicate when the illegitimate product was determined by your company using the same date format.
6. Select the Classification of Notification that best describes the product's status, such as Counterfeit or Stolen.
7. Fill in product details including Name, Primary Ingredients, Drug Use, and Description. Ensure accuracy for effective communication with FDA.
8. Complete additional fields like Strength of Drug, Dosage Form, Quantity, NDC Number, Serial Number, and Lot Numbers as applicable.
9. Describe any events/issues prompting this notification in detail to provide context for FDA review.
10. Finally, ensure all company information is accurate and complete before submitting your form through our platform.

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