Get the free FDA Form 2541d

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Process Filing for Nonacid Aseptic Systems (Form

How to fill out fda form 2541d

How to fill out FDA Form 2541d:

1. Begin by accessing the official FDA website or contacting your local FDA office to obtain a copy of FDA Form 2541d.
2. Read through the instructions and accompanying guidance to familiarize yourself with the purpose and requirements of the form.
3. Begin by providing your basic contact information, including your name, address, and telephone number.
4. Indicate the type of food facility you are operating, such as a manufacturer, distributor, or importer.
5. Provide details about your facility, including its name, physical address, and registration number.
6. Specify the type of food product you are producing or distributing, and indicate if it is a low-acid canned food or acidified food.
7. Fill out the production information section, including the establishment number, date of production, lot code, and other relevant details.
8. Record information about packaging and labeling, such as container type, labeling information, and any special handling instructions.
9. If applicable, provide information about any previous reprocessing or reconditioning of the product.
10. Sign and date the form to certify that all the information provided is accurate and complete.

Who needs FDA Form 2541d:

1. Food manufacturers that produce low-acid canned food or acidified food products.
2. Distributors and importers of low-acid canned food or acidified food products.
3. Facilities involved in the production or distribution of low-acid canned food or acidified food, as required by FDA regulations.

Note: It is important to consult the FDA guidelines and regulations to determine if your specific facility or food product falls under the requirement of FDA Form 2541d.

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