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See Instructions for OMB Statement. c. 1. REGISTRATION NUMBER (FDA Establishment Identifier) ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUEBASED PRODUCTS

How to fill out fda establishment registration and

How to fill out FDA establishment registration and?

1. Gather required information: Before beginning the FDA establishment registration process, ensure you have all the necessary information on hand. This may include company details (name, address, etc.), contact information, product categories, and intended activities.
2. Access the FDA online registration portal: Visit the FDA's official website and navigate to the establishment registration section. You will need to create an account or log in if you already have one.
3. Complete the registration form: Fill out the FDA establishment registration form with accurate and up-to-date information. Be thorough and provide all the required details, such as company name, address, phone number, email, and any applicable unique facility identifier (UFI) codes.
4. Determine your product categories: Specify the types of products your establishment manufactures, processes, packs, or holds. The FDA provides a comprehensive list of product categories, so choose the ones that apply to your business.
5. Specify your intended activities: Indicate the activities your establishment plans to conduct, such as manufacturing, processing, packing, holding, repacking, or relabeling products. Ensure that the selected activities accurately represent your business operations.
6. Pay the registration fee: The FDA establishment registration requires payment of a fee, which can be paid online using various payment methods. Verify the fee amount and follow the instructions provided on the registration portal to complete the payment.
7. Review and submit the registration: Carefully review all the information you provided before submitting the registration form. Double-check for any errors or missing details. Once you are satisfied with the accuracy of the information, submit the registration.

Who needs FDA establishment registration?

1. Manufacturers and processors: Any establishment involved in manufacturing or processing FDA-regulated products is required to complete the FDA establishment registration. This includes facilities producing food, drugs, medical devices, cosmetics, and dietary supplements.
2. Packagers and relabelers: Facilities responsible for packaging, repackaging, and relabeling FDA-regulated products must also undergo the FDA establishment registration process. This includes establishments that package or repackage food, drugs, medical devices, cosmetics, or dietary supplements.
3. Holders of FDA-regulated products: Establishments that hold FDA-regulated products, such as warehouses or distribution centers, are obligated to register with the FDA. This applies to facilities that are not involved in manufacturing, processing, packing, or labeling but handle these products.
4. Foreign establishments: FDA establishment registration is not limited to domestic facilities in the United States. Foreign establishments that manufacture, process, pack, or hold FDA-regulated products intended for commercial distribution in the United States must also register with the FDA.

Note: It is important to consult the FDA's official guidelines and requirements, as registration obligations may vary based on specific circumstances and product categories.

For pdfFiller’s FAQs

What is fda establishment registration and?

FDA establishment registration is the process by which a facility that manufactures, processes, packs, or holds food for consumption in the United States is registered with the Food and Drug Administration (FDA).

Who is required to file fda establishment registration and?

Any facility that is involved in the production or handling of food for consumption in the United States is required to file FDA establishment registration.

How to fill out fda establishment registration and?

FDA establishment registration can be filled out online through the FDA's registration website by providing information about the facility, including contact information, types of food handled, and number of employees.

What is the purpose of fda establishment registration and?

The purpose of FDA establishment registration is to provide the FDA with information about food facilities in order to help ensure the safety and security of the food supply.

What information must be reported on fda establishment registration and?

Information that must be reported on FDA establishment registration includes the facility's name and address, emergency contact information, type of food handled, and anticipated activities.

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