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FORM APPROVED: OMB No. 09100037; EXPIRATION DATE: 8312011. (See burden statement on page 2.) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TYPE OF SUBMISSION FOR FDA USE ONLY
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How to fill out form FDA 2541:

01
Begin by gathering all the necessary information and documents required to complete form FDA 2541. This may include the name and address of the establishment, as well as any relevant licenses or permits.
02
Start by filling out the basic information section of the form. This typically includes the name of the establishment, address, contact information, and the FDA registration number.
03
Indicate the type of food facility you are operating or owning. This could be a manufacturer, distributor, or importer, among others. Choose the appropriate category that best describes the nature of your establishment.
04
Provide details about the food products you produce or distribute. This includes information such as the FDA product code, brand name, product description, and packaging type.
05
If applicable, provide information on any labeling declarations required for your food products. This may include allergen information, nutrient content claims, or any other statements that must be included on the product labels.
06
Complete the sections related to the previous calendar year's food production, distribution, and sales. This includes providing information on the quantity of food produced, distributed, exported, imported, and converted for use in non-food applications.
07
Ensure that all the information provided is accurate and up-to-date. Double-check the form for any errors, omissions, or inconsistencies.
08
Sign and date the form to certify its accuracy and completeness.

Who needs form FDA 2541:

01
Food manufacturers: Those involved in the production and manufacturing of food products are required to submit form FDA 2541 to the Food and Drug Administration.
02
Food distributors: If you are involved in the distribution or sale of food products, this form is necessary to comply with FDA regulations.
03
Food importers: Individuals or businesses that import food products into the United States must complete form FDA 2541 to provide necessary information to the FDA.
In summary, form FDA 2541 must be filled out accurately and completely by food manufacturers, distributors, and importers. It is important to provide all the required information to ensure compliance with FDA regulations.
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Form FDA 2541 is a form used by food manufacturers to report their establishments and products to the U.S. Food and Drug Administration (FDA).
Food manufacturers are required to file form FDA 2541 to register their establishments and products with the FDA.
Form FDA 2541 can be filled out online through the FDA's website or by mail. It requires information about the establishment, products, and contact details.
The purpose of form FDA 2541 is to provide the FDA with information about food manufacturers and their products to ensure compliance with regulations and food safety standards.
Information such as the name and address of the establishment, contact information, types of products manufactured, and details on labeling and packaging must be reported on form FDA 2541.
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