CERTIFICATION IN INDIA

USA FDA FOOD REGISTRATION

What is USA FDA Food Registration?

USA Food Regulatory Agency of the Department of Health and Human Services has taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act from December 12, 2003.

  • Must submit establishment registration information, with consent to inspect the facility at any time as per the FDA protocol
  • Must renew food facility registrations every other year, with consent to suspend registration if found reasonable cause as per the protocol
  • Each food facility should have its own 11-digit registration number. If the same management has multiple facilities for manufacture and export to the USA, each of the facilities is required to register and obtain different food facility 11-digit registration numbers
  • FDA Food Facility registration is simple, but it is tiring and confusing for those doing it for the first time.

Benefits of USA FDA Food Registration

Reduced risk

Reputation

Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Who can be certified USA FDA Food Registration?

Baked goods

Beverages

Biscuits

Breakfast foods

Cakes

Canned (tinned) foods

Chips, crisps, corn snacks, nuts and seeds

Condiments

Dairy products

Egg products

Frozen foods

Meats

Shamkris Group

Merchant Exporter

Document required for USA FDA Food Registration

The extent of Documented Information differs as per:

Role of Shamkris and Process of USA FDA Food Registration

Shamkris adopts a results-oriented approach to compliance product registration, A simple & practical method of product registration in timely compliance, and fulfills the product registration requirement. Shamkris support 100% on documentation required to comply with product registration either by appointing a US representative or file directly if applicable.

The implementation process is described below:

Time Frame

Task

Process

Step 1

Appoint FDA Regulatory Expert & US Agent

Step 2

DUNS Request

Step 3

Fill online application & US agent Appointment Authorization

Step 4

Submit Application for FDA Registration

Step 5

Allocation of FDA 11 Digit Food Facility Registration Number.

Step 6

Receipt of Registration Certificate from US Agent

Time Frame

Step 1 to Step 6

Step 7

FDA Food Registration Renewal

FAQ

If you only invoice from your location and items shipped directly to the destination by the original manufacturer, then your facility need NOT to be registered with the FDA.

Food and Drug Administration never approve or disapprove any US Agent organization.

Yes. Data Universal Number System (DUNS) mandatory from 1st October 2020. Customers can find more information on websites.

  1. https://www.grants.gov/applicants/organization-registration/step-1-obtain-duns-number.html
  2. https://www.dnb.com/duns-number/get-a-duns.html
  3. https://fedgov.dnb.com/webform/

Yes, the manufacturer registration is a must! In case of any food quality issues, the FDA will conduct an ONSITE audit as per 21 CFR 110 or 21 CFR 111.

The MANUFACTURER  / Manufacturing Facility must register with FDA.

If the exporter stores food at the facility, the same facility also must register with FDA. If you just invoice and the manufacturer sends it to the destination, your facility need NOT register.

NO. The FDA Food Facility Registration number is confidential.  You need to mention it only at the time of sending a prior notice.