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FORM FDA 3613-2026

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  2. Begin by filling out Section 1A, which includes your requestor information. Enter your name, firm, address, telephone number, and email address. Ensure all details are accurate for smooth processing.
  3. In Section 1B, provide the billing address if it differs from the requestor's address. If applicable, include an alternate billing email address.
  4. Proceed to Section 2 for manufacturer information. Fill in the firm name, address (no P.O. Boxes), registration number, license number (if any), and date of last FDA inspection for each manufacturer involved.
  5. Complete Section 4 by entering product information such as trade name and marketing application number. Be thorough to avoid delays.
  6. Finally, review all sections for accuracy before signing the Exporter’s Certification Statement at the end of the form.

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