Get the free fda form 3486

FDA USE ONLY DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Date Received: BIOLOGICAL PRODUCT DEVIATION REPORT Date Reviewed: BPD ID: BPD No. * Indicates required information

How to fill out fda form 3486

How to fill out FDA Form 3486:

1. Start by providing the required general information on the form, such as the name and address of the establishment and the contact person.
2. Indicate the specific type of operation being conducted, whether it is for a domestic facility, foreign facility, or a foreign deliverer for purposes of the Drug Supply Chain Security Act (DSCSA).
3. Complete the "I am an authorized individual" section by providing your name, contact information, and signature, confirming that you are authorized to submit the form on behalf of the establishment.
4. Fill out the "Voluntary Information" section, which includes questions about current Good Manufacturing Practices (cGMP) compliance, facility classifications, and whether the facility wants to be considered for expedited review.
5. Provide any additional relevant information or attachments as required, such as a cover letter or supporting documentation.
6. Review the completed form for accuracy and ensure all mandatory fields have been properly filled.
7. Submit the filled out FDA Form 3486 through the designated submission process, whether it is online through the FDA's Unified Registration and Listing System (FURLS) or by mail.

Who needs FDA Form 3486:

1. Pharmaceutical establishments: Any domestic or foreign facility engaged in the manufacturing, packing, or labeling of drugs for commercial distribution in the United States may need to fill out FDA Form 3486.
2. Foreign deliverers: Entities involved in delivering drugs or active pharmaceutical ingredients (APIs) to a domestic establishment as part of the Drug Supply Chain Security Act (DSCSA) may also require this form.
3. Facilities subject to inspections: FDA Form 3486 serves as a means for establishments to register with the FDA and provide necessary information for inspections and compliance purposes.

Overall, anyone involved in drug manufacturing, distribution, or delivery may need to fill out FDA Form 3486 to ensure compliance with FDA regulations and facilitate communication with the agency.

For pdfFiller’s FAQs

What is fda form 3486?

FDA Form 3486 is a form used by the Food and Drug Administration to collect information about imported food products.

Who is required to file fda form 3486?

Importers of food products into the United States are required to file FDA Form 3486.

How to fill out fda form 3486?

FDA Form 3486 can be filled out online through the FDA's website or submitted physically by mail. Importers need to provide information about the imported food products, including the product name, manufacturer, ingredients, and country of origin.

What is the purpose of fda form 3486?

The purpose of FDA Form 3486 is to ensure the safety and compliance of imported food products entering the United States.

What information must be reported on fda form 3486?

Information such as the product name, manufacturer, ingredients, country of origin, and intended use must be reported on FDA Form 3486.

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