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FDA Quick Links & Resources

When starting a food business you need to know the regulations pertinent to your food product(s). We have compiled a list of FDA website links and resources by category you may need for your business:
 
 
REGISTRATION OF FOOD FACILITIES
To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that food facilities register with FDA.

Food Facility Registration (FFR) provides your facility registration # and PIN
 
Registration of Food Facility Website
Food Facility Registration User Guide: Step-by-Step Instructions
 
ACIDIFIED FACILITY REGISTRATION
A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods (AF) shall register with FDA. This is completed by filling our Form FDA 2541.

Section 1: Type of Submission
Section 2: Food Processing Plant Location
Section 3: Preferred Mailing Address
Section 4: Foods Processed at Location
Section 5: Establishment Contact Person

At the end of filling out electronic form, you will receive:
FCE # is ________ (this number remains with physical plant location)
 
Form FDA 2541
Instructions for Electronic Submission Form FDA 2541
 
FOOD PROCESS FILING FOR ACIDIFIED FOODS
​A commercial processor engaged in the processing of an acidified food shall provide FDA with information, using Form FDA 2541e, on the scheduled processes for each acidified food in each container size.

For each process filing, there will be a unique SID number. The SID consists of (1) the year, month, and day of the month that a process filing form is created, and (2) a unique sequence number to identify each form when multiple forms are created on the same date.
 
Form FDA 2541e
Instructions for Electronic Submission Form FDA 2541e
 
FDA FSMA
The Food Safety Modernization Act (FSMA) is the most sweeping reform of the food safety laws in over 70 years. The FSMA was signed into law by President Obama on January 4, 2011. FSMA aims to protect public health by focusing on prevention of, rather than reaction to, food safety issues. FSMA is administered through the United States Food and Drug Administration (FDA).

Accredited Third-Party Certification
Qualified Facility Attestation – Draft Guidance
Preventative Controls for Human Food
Preventative Controls Rules FAQs

Written By

Photo of Allison SainAllison SainExtension Assistant (919) 515-3344 Allison_Sain@ncsu.eduFood, Bioprocessing and Nutrition Science - NC State University
Page Last Updated: 6 months ago
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