Tag: Biennial Renewal

FDA Food Facility Biennial Registration Renewal

FDA requires all registered domestic and foreign food and dietary supplement facilities to renew their FDA registration every two years. This applies to all the facilities that manufacture, process, pack, or store food, beverages, or dietary supplements intended for consumption in the USA.

  1. Initial Registration: Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the US must register with FDA.
  2. Registration Renewal: FDA registration must be renewed between October 1 and December 31 of every even-numbered year. Next renewal period is October – December 2024.
  3. Purpose of FDA Registration: FDA registration helps the FDA to regulate food facilities effectively and share important information related to food safety.
  4. Penalties: FDA registrations that are not timely renewed get cancelled and shipments of such facilities are refused admission into US

Biennial renewal of food facility registration with the FDA is important for several reasons:

Up-to-date Information:

The biennial renewal process helps the FDA maintain accurate and up-to-date information about facilities. This includes the address, contact details, and the types of activities conducted at the facility. Accurate data is essential for the FDA to respond quickly in case of a food safety issue.

Food Safety:

The renewal process supports the FDA’s ability to monitor and inspect food facilities to ensure compliance with food safety standards. This is crucial for preventing foodborne illnesses and ensuring that food products entering the US market are safe for consumption.

Compliance with FSMA:

FSMA mandates the registration and regular renewal of food facilities. Failure to renew registration can lead to a facility being considered non-compliant, which may result in legal actions, such as the refusal of food shipments, or being prohibited from distributing food in the US.

Efficient Communication:

Up-to-date registration information helps ensure that the FDA can communicate efficiently with facilities in case of emergencies, such as recalls, outbreaks, or other food safety concerns. Efficient communication is key to mitigating risks and protecting public health.

Preventing Market Disruptions:

Timely renewal helps prevent disruptions in the supply chain. If a facility fails to renew, it may face legal or logistical hurdles that may prevent its products from entering the US market, causing potential losses and supply issues.

Liberty management Group Ltd. can help companies with FDA Registration and biennial registration renewal.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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

Who needs to register with FDA?

Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.

Facilities that are exempt are:

  1. Farms
  2. Restaurants
  3. Retail Food Establishments e.g. grocery stores
  4. Nonprofit Food Establishments
  5. Fishing Vessels
  6. Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
  7. Private residence of individuals
  8. Post Offices, Freight Forwarders

While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.

In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.

Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 06, 2019