Tag: UFI

What is DUNS number? Why is it important to obtain DUNS?

The Data Universal Numbering System or DUNS number is a unique 9-digit identification number provided by Dun & Bradstreet (D & B). The DUNS Number is location specific. So, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a separate DUNS number.

All domestic and foreign food facilities are required to provide a Unique Facility Identifier (UFI) when registering with FDA. Currently DUNS number is the only acceptable UFI recognized by FDA.

FDA intends to conduct the verification process for UFI as below:

  1. For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.
  2. For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUNS number first. DUNS requests may take up to 30 days.

Liberty Management Group Ltd can help you with FDA registrations, renewals and DUNS lookup. For assistance, please visit our website www.fdahelp.us

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Re-Registration of Food Facility Registrations & UFI Requirement

As per FDA regulation, food facilities that are registered with FDA are required to renew such registration between Oct – Dec every even numbered year (2022, 2024, 2026…). If a facility fails to renew the registration by the deadline, FDA will consider such registration as expired & remove it from the FDA system.

Such facilities that wish to market their products in US will need to re-register with FDA. Facilities looking to re-register due to incomplete biennial renewal will need to provide their old FDA registration number on new application & FDA will reassign the same registration number to them. If the registration was cancelled because of any other reason, facilities will need to submit a new registration & will be assigned a new FDA registration number.

Beginning October 1, 2020, domestic and foreign facilities will need to provide a UFI (Unique Facility Identifier) recognized as acceptable to FDA in existing and new food facility registrations. Currently, FDA recognizes DUNS (Data Universal Numbering System) as the only acceptable UFI for the food facility registrations. FDA will not confirm a facility’s biennial renewal or assign a registration number if a valid DUNS number is not provided on registration.

Liberty Management Group Ltd. can help you with FDA registration, re-registration and DUNS.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

UFI for FDA Food Facility Registrations

FD&C Act requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in US to register with FDA. The FSMA Act amended the food facility registration requirements requiring food facilities to renew the registrations between Oct – Dec every even numbered year and to provide an FDA recognized Unique Facility Identifier (UFI) in their FDA registration. As per the regulation FDA will not confirm a facility’s new registration or renewal until FDA verified the accuracy of the UFI and verified that the facility-specific address associated with UFI matches with the facility’s information in registration.

FDA intends to conduct the verification process for UFI as below:

  1. For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.
  2. For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

In August 2018, FDA recognized Data Universal Numbering System D-U-N-S (DUNS) as an acceptable UFI for the food facility registration regulation. The DUNS number is assigned and managed by Dun & Bradstreet and is available free of charge.

Liberty Management Group Ltd can help you with biennial registration renewal and DUNS update. For assistance, please visit our website.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 07, 2022