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Contains Nonbinding Recommendations Instructions for Completing Form FDA 3480: OMB No. 0910-0495; Expiration Date: 02/29/2016 Department of Health and Human Services Food and Drug Administration Food
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How to fill out FDA Form No. 3480:

01
Start by carefully reading the instructions provided with the form. Make sure you understand all the requirements and sections before proceeding.
02
Begin filling out the top section of the form, which typically includes your personal information such as name, contact details, and any identification numbers required.
03
Move on to the next section, which will likely require you to provide information about the product or activity for which the form is being submitted. Include all relevant details accurately and thoroughly as requested.
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If the form requires you to provide supporting documentation or attachments, ensure that you gather and attach them appropriately. This may include labels, product samples, or laboratory test results, depending on the nature of the form.
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Double-check your completed form for any errors, missing information, or inconsistencies. Accuracy is crucial, as errors may delay the processing of your form or lead to its rejection.
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Once you have reviewed and verified all the information provided, sign and date the form as required. This serves as your attestation to the accuracy and completeness of the information you have provided.
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Depending on the specific instructions, you may need to submit the form electronically, by mail, or in person. Follow the instructions provided to ensure the form reaches the appropriate destination.

Who needs FDA Form No. 3480?

01
Companies or individuals involved in activities or products that require regulatory oversight from the Food and Drug Administration (FDA) may need to fill out FDA Form No. 3480.
02
This form may be required for various purposes, such as obtaining product approval, registering facilities, or submitting information related to the manufacturing, distribution, or marketing of FDA-regulated products.
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Different industries and sectors, such as pharmaceuticals, medical devices, cosmetics, dietary supplements, food manufacturers, and others, may have specific requirements for which this form becomes necessary.
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It is crucial to carefully review the specific regulations and guidelines within your industry or product category to determine if FDA Form No. 3480 is required for your business or activities.
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Additionally, individuals seeking to import or export FDA-regulated products may also find themselves needing to complete this form to ensure compliance with relevant regulations.
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Failure to fill out FDA Form No. 3480 when required or providing inaccurate or incomplete information may result in regulatory penalties, delayed approvals, or other legal consequences.
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If unsure whether your specific situation requires FDA Form No. 3480, it is recommended to consult with an expert in FDA regulations or reach out to the FDA directly for guidance.
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