Get Instructions For Paper Submission Of Form Fda 2541d - Fda

This guide provides a comprehensive overview of how to accurately complete the Instructions for Paper Submission of Form FDA 2541d. Designed for users with varying levels of expertise, it aims to simplify the process and ensure compliance with submission requirements for thermally processed low-acid foods.

Follow the steps to successfully complete your Form FDA 2541d submission.

1. Click ‘Get Form’ button to access the form and open it in your preferred editor.
2. At the top of Form FDA 2541d, provide your Food Canning Establishment (FCE) number and Submission Identifier (SID). Leave the 'Date Received by FDA' blank, as this is for FDA use only.
3. Proceed to Section A. Product Information. This includes entering an optional Food Product Group, the product name in English (and foreign language if applicable), the form of the product, and its packing medium.
4. Move to Section B. Governing Regulation. Here, acknowledge that Form FDA 2541d pertains to thermally processed low-acid foods under 21 CFR 108.35 and Part 113.
5. In Section C. Container Type, select a single type of container used for your product and provide details on its shape, construction, and use of divider plates if applicable.
6. For Section D. Container Size, report the dimensions of your container according to its shape. Follow the instructions for reporting size in the correct format.
7. Under Section E. Processing Method, you will describe the finished equilibrium pH of your product and the heating medium used to process it.
8. Section F. Process Mode requires you to select the processing mode and type of cooker used.
9. Complete Section G. Process System Critical Factors by providing information about filling methods and the product's container position in the retort.
10. In Section H. Product Critical Factors, provide answers about the product’s characteristics, such as presence of particulates, dry ingredients, and their arrangement in the container.
11. Proceed to Section I. Process Source. Enter the name of the individual or entity that established the scheduled process and the date of the supporting document.
12. In Section J. Scheduled Process, list the detailed scheduled processes and their respective parameters including process numbers, minimum initial temperatures, and times.
13. Finally, in Section K. Additional Information, you may provide optional heat penetration data and any comments relevant to your submission.
14. Ensure to sign and date the form at the end, providing the full name and details of the authorized representative.
15. Save your completed form, then download, print, or share it as needed for your records.

Complete your Form FDA 2541d online today to ensure your submissions are compliant with FDA regulations.