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Form: OMB No. 09100027. Expiration Date: 09/30/2020
See Burden Statement on Reverse of Part I.DEPARTMENT OF HEALTH AND HUMAN SERVICESTYPE OF SUBMISSIONFOOD AND DRUG ADMINISTRATIONORIGINALCollege Park,
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Start by obtaining form FDA 2512 from the official FDA website.
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Read the instructions carefully and gather all the required information and documents.
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Fill in your personal information accurately, including your name, address, and contact details.
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Provide the necessary details about the product or activity being reported, such as the name, purpose, and intended use.
05
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Submit the form to the designated FDA office or through the appropriate online portal.
Who needs form FDA 2512:
01
Manufacturers or distributors of food, drugs, cosmetics, medical devices, or dietary supplements may need to fill out form FDA 2512.
02
Those seeking to report adverse events, defects, or other incidents related to FDA-regulated products may also be required to use this form.
03
Individuals or organizations involved in clinical trials or research studies may need to submit form FDA 2512 to report their findings or data.
Please note that the specific requirements for form FDA 2512 may vary depending on the nature of the product or activity being reported. It is essential to refer to the latest instructions and guidelines provided by the FDA for accurate and up-to-date information.
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What is form fda 2512?
Form FDA 2512 is a form used for the reporting of information related to the importation of certain food products into the United States.
Who is required to file form fda 2512?
Importers or agents of importers who are bringing food products into the United States must file Form FDA 2512.
How to fill out form fda 2512?
Form FDA 2512 should be filled out by providing detailed information about the food product, including its description, quantity, origin, and any additional required information based on the product type.
What is the purpose of form fda 2512?
The purpose of Form FDA 2512 is to assist the FDA in ensuring that imported food products meet safety standards and comply with U.S. regulations.
What information must be reported on form fda 2512?
The form requires information such as the product name, quantity, country of origin, responsible party's contact information, and details related to the shipment.
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