Get Hhs Form Fda 3613 2021-2025

The HHS Form FDA 3613 is essential for obtaining certificates related to the export of regulated products. This guide aims to assist users in accurately completing the form online, ensuring compliance with regulatory requirements.

Follow the steps to successfully complete the HHS Form FDA 3613 online.

1. Click the ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by entering your requestor information in section 1A, including your name, firm, address, telephone number, fax number, firm tax ID code, and email address.
3. In section 1B, provide the billing address if it differs from the requestor's address. Include an alternate billing email address if necessary.
4. Proceed to section 1C to provide your shipping account number and/or label for mailing supplies, if applicable.
5. In section 2, input the manufacturer information. Complete this section separately for each firm, ensuring to include the firm name, address (note: P.O. Box not acceptable), registration number (Firm Establishment Identifier), license number (if applicable), and the date of the last FDA inspection.
6. Continue filling out section 3 for distributor information, if relevant. Ensure that the distributor listed has a U.S. address.
7. Complete section 4 with the product information, including trade name, proper name, and marketing application number.
8. In sections 5A and 5B, respond to questions about any past recalls and injunctions related to the product. Provide necessary details if applicable.
9. Indicate the country for which the certificates are requested in section 6. In section 7, specify the product information that should appear on the certificate.
10. Answer whether the destination country should be listed on the certificate in section 8, and indicate the total number of certificates requested.
11. Finalize the form by reviewing all fields for accuracy. Once complete, you can save changes, download, print, or share the form as needed.

Start filling out your HHS Form FDA 3613 online today to ensure compliance and timely processing.