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INVESTIGATIONS OPERATIONS MANUAL 2015 EXHIBIT 4-13 SAMPLE NO. AFFIDAVIT STATE OF 55545 COUNTY OF Tennessee Shelby Before me, Sidney H. Rogers, an employee of the Department of Health and Human Services,

How to fill out fda affidavit

How to fill out an FDA affidavit:

1. Begin by obtaining the appropriate form: To fill out an FDA affidavit, you need to start by acquiring the correct form. You can usually find the form on the official website of the U.S. Food and Drug Administration (FDA) or through other authorized sources.
2. Provide accurate contact information: The first section of the affidavit requires you to provide your personal details, including your full name, address, phone number, and email address. Make sure to double-check the accuracy of this information as it will be used for any future correspondence.
3. State the purpose of the affidavit: Clearly state the purpose of the affidavit in the designated section. This might include explaining the nature of your involvement with a specific FDA-regulated product or any relevant details regarding a violation or complaint.
4. Describe the details: In this section, you will need to provide a detailed account of the specific incident or circumstances that led you to fill out the affidavit. Include dates, times, locations, and any other relevant information that will help clarify the situation.
5. Attach supporting documents: If you have any supporting documents, such as photographs, videos, invoices, or product labels, make sure to attach them to the affidavit. These documents can provide essential evidence to support your claims or concerns.
6. Sign and date the affidavit: Once you have completed all the required sections, carefully read through the affidavit to ensure its accuracy. Sign and date the form in the designated areas to validate the information provided.
7. Submit the affidavit: Finally, follow the instructions provided on the form to submit your completed affidavit to the appropriate FDA office or department. This may involve mailing the document or submitting it electronically, depending on the specified requirements.

Who needs an FDA affidavit?

1. Individuals reporting violations: If you suspect a violation related to an FDA-regulated product, you may need to complete an FDA affidavit. This can be done by individuals who have first-hand knowledge or evidence of any non-compliance with FDA regulations.
2. Consumers with complaints: If you have experienced adverse health effects or any other issues related to an FDA-regulated product, filling out an FDA affidavit can help ensure your complaint is thoroughly investigated.
3. Industry professionals: Individuals involved in the manufacturing, distribution, or marketing of FDA-regulated products may also be required to fill out FDA affidavits as part of compliance measures or during inspections.

Overall, anyone with pertinent information or concerns about FDA-regulated products can potentially benefit from filling out an FDA affidavit. It is important to consult the official FDA guidelines and specific requirements for the particular situation to ensure the affidavit is completed correctly.

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What is fda affidavit?

FDA affidavit is a document required by the Food and Drug Administration for certain food facilities to attest that they are in compliance with the regulations.

Who is required to file fda affidavit?

Food facilities that manufacture, process, pack, or hold food for human or animal consumption are required to file FDA affidavit.

How to fill out fda affidavit?

FDA affidavit can be filled out online on the FDA's website or in paper form and submitted to the FDA.

What is the purpose of fda affidavit?

The purpose of FDA affidavit is to ensure that food facilities are following the regulations set forth by the FDA to protect public health.

What information must be reported on fda affidavit?

Information such as contact details of the food facility, types of foods being manufactured, processed, packed, or held, and compliance with FDA regulations must be reported on FDA affidavit.