Fda registration number. May 19, 2025 · Search for the U.

Fda registration number Note that registration or listing does not imply approval by FDA. This process ensures compliance with health regulations and opens the doors to one of the world’s most competitive markets. Feb 3, 2025 · FDA license number in Thailand, and how it ensures product safety. Dec 11, 2024 · The table below provides additional information regarding these common errors to help you provide accurate and complete information to the FDA. Dec 1, 2020 · U. Current Guidance: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration establishes the DUNS number as the UFI required for Registration and Listing May 12, 2021 · FDA published in the Federal Register of August 31, 2016 (81 FR60170) a final rule that amended FDA’s regulations governing drug establishment registration and drug listing, including FSMA data search and informationSearch the FDA firm and supplier database, which includes the following: compliance information, recalls, import alerts and refusals where applicable. Jul 15, 2025 · What is an FEI number? Learn the meaning of an FDA Establishment Identifier (FEI), who needs one, how to get it, and how it differs from registration numbers. Importers can import foods into the United States Step-by-step instructions on how to update a food facility registration online. If you have paid for your registration (s) and do not have your PIN and PCN, you can display your numbers by visiting the FDA User Fee website. market must register with the FDA. Any representation of FDA registration number on product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product. Registration numbers in the FDA database are categorized according to the establishment name, product code, establishment type, and establishment country or state. This guide shows you how to use official resources to confirm facility registration and understand its significance. Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry1 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. This is because the FDA aims to honor medical device establishments’ sovereignty and exclusivity rights over the import and marketing of their products. The 5-Step FDA Registration Journey FDAbasics streamlines your path to compliance into five clear, managed Aug 31, 2016 · Please refer to the Drug Establishment Registration and Listing or Device Registration and Listing webpages for additional information. May 19, 2025 · Search for the U. Jan 31, 2025 · FDA Databases: a listing of public databases for regulations, good practices, medical devices, drug and cosmetics products. Product listing information is searchable by product name and category. A food facility registration number is assigned when a facility registers through the FDA food facility registration portal (available here). Save now on New FDA Registration or Renewal. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Food and Drug Administration Food Facility Registration User Guide: Registration of Food Facilities – Step-by-Step Instructions Once you have entered a registration number and a ‘Validated by FDA’ date, click on the 'Add This Establishment' button to submit your request for access to this establishment. Use the business name as your primary search criteria. Learn how to register your facility and products with the FDA for different categories, such as drugs, cosmetics, food, medical devices, and tobacco. Prior Notice) to the U. Feb 20, 2020 · Assigning each registered manufacturer a registration number makes it easy to conduct an FDA facility registration number lookup in the appropriate FDA registration database to determine whether a specific manufacturer is registered and in compliance. Previously registered facilities should renew the registration between October 1 and December 31 of each even-numbered year starting from the year 2012. Under the U. Food and Drug Administration must renew their registration this year before December 31. market smoothly. This page contains a list of contact information for the FDA Import Program by topic. The FDA registration number is used to identify registered facilities and track products manufactured or distributed by those facilities. Recently, FDA released two guidance documents to help food facilities meet their registration FDA Affirmations of Compliance – Quick Reference FDA. The process for assigning registration numbers varies from product category to product category. You may separately search the list using the ticker symbol. It is used by the FDA to track inspections, compliance, and regulatory activities related to a company. It’s the inventory number the FDA uses to keep track of all the establishments we regulate. Aug 18, 2020 · One you have registered initially, FDA requires all registered food facilities to renew their registration between October 1 and December 31 of each even-numbered year (meaning this year—2020—is a renewal year, if you are already registered). ; 2) you have already paid the annual registration user fee and received your Payment Identification Number (PIN) and Payment Confirmation Number (PCN); and, 3) the owner/operator has no other registered facilities. It View Your Registration and Listing Information May, 2025 Table of Contents View Facility Information View Listing Information View all information on record for any facility or medical device listing associated with your account. Nov 17, 2025 · This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. You can enter a premarket submission number, a company name, registration or owner/operator number to search for registration and listing information. Learn their purpose, who requires one, the application process, and how to maintain compliance. Here’s how to do it and how we can help. Dec 11, 2024 · FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers, products, labels, or shipments. Nov 17, 2025 · Registration Number: 1181121 FEI Number*: 1181121 Status: Active Initial Distributor/Importer: Yes *Note Firm may have additional establishment types. Biennial Food Facility Registration and Renewal August 11, 2022 -Presented by Nicole Shokatz, Management Analyst, Data Systems Integration Branch, DFPG, CFSAN and -Robert Spear, acting Food Facility Program Manager, Data Systems Integration Branch, DFPG, CFSAN Previously, this guidance restated FDA’s food facility registration regulations. Nov 8, 2024 · No. If you … . It is a common misconception that both being DUNS Number Requirements for Food Facility Registration with FDA - FAQ After the December 31st, 2022, biennial renewal period, FDA has stopped accepting any food facility registrations or renewals for facilities that do not have a valid DUNS number. Date of Registration Status: 2025 Owner/Operator: Thermo Fisher Scientific 168 Third Avenue Waltham, MA US 02451 Owner/Operator Number: 2517925 FDA Establishment registration is site-specific, and each manufacturing location must register separately and have its own DUNS number; FDA will assign a unique FEI number for each location. The FDA requires food facilities renew their registration every even-numbered year, and any medical device or drug facility must be registered and listed annually. Please review listings for further information. The SRO list is a comprehensive and important resource to check Oct 30, 2025 · Find FDA-registered outsourcing facilities for safe human drug compounding, with compliance updates, quality standards, and verified facility information. However, FDA encourages use of the electronic format at this time because it is more efficient, provides for immediate submission of the registration information, and provides for immediate issuance of the registration number. You will be prompted to enter a valid Payment Identification Number and Payment Confirmation Number (PIN/PCN) to complete your annual registration. DEA Form 224a – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner DEA Form 225a Current Guidance: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration establishes the DUNS number as the UFI required for Registration and Listing In conjunction with this initiative, firms registered with FDA, or of which FDA is otherwise aware, may expect to be contacted by Dun & Bradstreet personnel. What is FDA Registration? Establishments or facilities that manufacture, label, package, or perform certain other operations on foods, drugs, medical devices, tobacco, or biologics are required to register with FDA. Registrar Corp will verify FDA registration at no cost so that suppliers can quickly determine whether their registrations are valid This web page explains the onsite registration and listing verifications that FDA has contracted Dun & Bradstreet to perform. Enter/Find Registration -- Step 2 Enter the registration number for the facility that you want to retrieve PIN information for and select “ Find Registration ” (Figure 2). GOV Effective Date: September 18, 2021 Page 2 of 3 Effective Date: September 18, 2021 Nov 10, 2021 · NDCs should not be assigned to non-drug products such as medical devices and medical foods. About Us Liberty Management Group Ltd is a globally recognized FDA The FDA may invalidate a facility’s registration for a number of reasons, from lack of current information to missing renewal deadlines. Nov 4, 2024 · Learn the essential steps and requirements for FDA registration and drug listing for pharmaceutical companies. So, how can one proceed to register an FDA food facility, and what are the renewal timelines? Today’s article invites us to examine this alongside UCC! manufacturers of FDA regulated products know that FDA registration number is a mandatory requirement, but most of them are not aware of other FDA requirements like, GMP, listing, label compliance, UDI, prior notice, etc The drug establishments current registration site is a publication of currently registered establishments which manufacture, prepare, propagate, compound or process drugs that are distributed in Oct 21, 2024 · Report an emergency If you are experiencing a life-threatening medical emergency, call 9-1-1. Summary and definitions of field names used in the online Food Facility Registration system. It is a common misconception that both being Establishment Registration and Listing for Human Drugs Highlighting Recent Amendments to 21 CFR Part 207 David Joy and Paul Loebach FDA, Center for Drug Evaluation and Research September 2016 Dec 11, 2024 · FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers, products, labels, or shipments. Food And Drug Administration registration numbers using the FDA website at FDA. All our prices are published on the LMG website, which will help you calculate the total cost involved before starting the project. Nov 17, 2025 · Establishment Registration & Device ListingFDA Home Medical Devices Databases Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Oct 31, 2025 · This database is refreshed daily to include product listings & tobacco establishments registered through the FDA. 13-digit FDA registration structure and significance for health products. Domestic, First Registration in Account This tutorial should only be used when 1) registering a facility that is located in the U. gov Registration and Listing of OTC drug products Please Mar 3, 2021 · How to know if a medical device is FDA-approved, cleared, or authorized. Therefore, understanding the FEI number, the registration process, and its distinction from the DUNS number is essential for businesses in the food, drug, cosmetic, and medical device industries. How to search FDA registration number How to search FDA registration number Answer to the question “ How to search FDA Registration Number ” depends on the type of product. Registered facilities are issued a Food Facility Registration (FFR) number. Any representation of the FDA registration number on product labels or labeling which creates an impression of US FDA approval may cause misbranding of the product. This directly impacts the overall success of the registration process, making it an essential consideration. Sep 15, 2025 · An FDA Establishment Identifier (FEI) Number is a unique identifier assigned by the U. market access. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics and Evaluation Research (CBER) Establishment Registration To Update Establishment Information Step 9 : The FEI number is required after initial registration. Learn how to find your FDA registration number for different types of products and establishments in the US. Provides information on the registration and listing of cosmetic product facilities and products with the U. Aug 27, 2025 · Navigate FDA registration numbers. Learn More Jan 31, 2025 · FDA Databases: a listing of public databases for regulations, good practices, medical devices, drug and cosmetics products. MAIL COMPLETED FORM FDA 3537 TO U. May 18, 2025 · Learn FDA drug establishment registration and listing rules, FEI use, and how to stay compliant under 21 CFR 207 for U. REGISTRATION NUMBERS The summary report has two registration numbers, FEI and CFN. Nov 17, 2025 · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. To view this information, navigate to the links provided below. You can search the list by entering the DUNS NUMBER, BUSINESS NAME, or TICKER SYMBOL in the search criteria. Additionally, intermediary firms, including traders, importers, and distributors, must also register if they Latest News 9-14-2023 – FDA is updating the marketing category and application number fields for over-the-counter (OTC) monograph drugs in eDRLS. A registered facility receives a unique registration number from FDA which FDA uses to identify the firm for inspections, exams, screening of imported products, and other Nov 7, 2023 · Discover how to obtain your FDA Food Facility Registration Number. Food and Drug Administration (FDA) to each facility or establishment involved in the manufacturing, processing, packing, or holding of FDA-regulated products. How does an FEI differ from a UFI or DUNS number? FDA Registration Fees Liberty Management Group LTD offers the most competitive fees for FDA registration, US FDA agent service, NDC number request, Drug listing, Label review, and other services. Welcome to FDA Verification Portal This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively. In the FDA registration process, a crucial aspect is how to register an FDA food facility. Review Registration Information Screen After clicking Submit, a payment confirmation number entry screen will appear. Nov 8, 2023 · During this time, a facility can use its owner/operator number and device listing number (if applicable) to import its medical devices into the United States until the FDA assigns a registration FDA registration is an essential step for exporting products like food, cosmetics, and medical devices to the United States. In conjunction with this initiative, firms registered with FDA, or of which FDA is otherwise aware, may expect to be contacted by Dun & Bradstreet personnel. You'll learn how to reach out to the FDA's registration and listing helpdesk to retrieve your number. The FDA electronically reviews all FDA-regulated entries This page contains information on when to register and list medical devices. Each registration renewal must include the name of the individual submitting the registration renewal, and the individual's signature (for the paper option). Tobacco establishments registered with FDA; and Tobacco products listed with FDA. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies. S. 245. Apr 4, 2025 · Please mail the completed form to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at: Food and Drug Administration, Office of Cosmetics and Colors Aug 3, 2021 · If you have questions about registration information or suggestions on improving this Public query, please contact the Blood Registration Coordinator - email bloodregis@fda. Registration information is searchable by establishment name, operation type, state, owner name, operator name, and FEI number. Assure compliance and maintain seamless operations in the Food & Beverage industry. Click on the topic name to view the contact information. Registration of a drug establishment or drug wholesaler or assignment of a registration number or assignment of NDC number does not in any way denote approval of the company or its products. In addition, the registration renewal must also identify the individual who authorized submission of the registration renewal by email address, unless FDA has granted a waiver under § 1. A registered medical device establishment is required to provide a registration or owner/operator number and listing number(s) to facilitate the shipment of the device into the United States. Learn how to register your food facility with the FDA, including eligibility, required information, step-by-step process, and biennial renewal. and foreign human and animal food facilities that are required to register with the U. The FDA registration renewal process differs depending on the products category. This guide breaks down the essential Food Facility Registration process, highlighting the key steps, requirements, and compliance considerations managed by experts at FDAbasics. DUNS number is now a mandatory requirement. However, the list does not contain all the domestic and foreign stock exchange ticker symbols in existence. Select Viewing Option Screen View Facility Information If you select "View Your Registered Facilities," all registrations under your account will be displayed The MDUFMA II amendments require that all registration and listing information be submitted electronically unless FDA grants you a waiver. Questions and Answers Regarding Food Facility Registration (Seventh Ed ition): Guidance for Industry1 This guidance represents the current thinking of the Food and Drug Administration (FDA or we … A valid Registration [FDA Establishment Identifier (FEI)] or CLIA Number is required to use this system. Jun 28, 2022 · Regulation of OTC products Marketed under OTC Monographs (All Categories) Toll Free (855) 543-3784, or (301) 796-3400 druginfo@fda. Food and Drug Administration. Note: Registration of an establishment, assignment of an FDA Establishment Identifier (FEI) number, or listing of a product does not 15. Facility Registration & Listing One of the most basic requirements for selling FDA-regulated products is to make sure they are properly registered and sometimes listed with the FDA. FDA Bioterrorism Act of 2002, all domestic and foreign facilities that manufacture, process, pack, or store food, beverages, or dietary supplements for the U. thaifdaregistration. You must submit a food facility registration number to FDA for shipments of food exported (e. If a registration number exists, but you do not know it, the screen will provide a link to the FDA Search Registration Database site where you can search for the Registration number. What do these mean? The FEI stands for FDA Establishment Identifier. FOOD AND DRUG ADMINISTRATION, HFS-681, 5001 CAMPUS DRIVE, COLLEGE PARK, MD 20740, OR FAX IT TO 301-436-2804 Date Registration Form Received (mm/dd/yyyy) The FDA has a number of resources available to help facilities register and renew their registration. Add, delete, or edit product listings. This video is ideal for businesses in the food, drug, and medical device industries. Mar 3, 2021 · How to know if a medical device is FDA-approved, cleared, or authorized. Perfect for FDA-regulated businesses. Find guidance, forms, and links to electronic submission systems for each category. Common Medical Device Look-up errors that result in This page contains information on when to register and list medical devices. If any of the mandatory Questions and Answers Regarding Food Facility Registration (Seventh Ed ition): Guidance for Industry1 This guidance represents the current thinking of the Food and Drug Administration (FDA or we Edit the address or phone number for a facility. g. food market requires strict adherence to FDA rules. Nov 17, 2025 · Establishment Registration & Device ListingFDA Home Medical Devices Databases After an establishment's registration form is processed, FDA will send the Reporting Official a validated form, which includes the registration number (FEI #). Aug 27, 2025 · Verify FDA registration numbers with confidence. All drug, food, biologic, device, radiology, veterinary medicine facilities, and importers of these products have FEIs. Learn More FDA registration number is a unique identifier assigned by the US Food and Drug Administration (FDA) to facilities that manufacture, process, pack, or store food, drugs, medical devices, or cosmetics intended for consumption or use in the United States. If you fail to renew your registration, FDA considers the registration expired. . Renewal Applications Renew Your Application HERE! EMAIL ADDRESSES ARE REQUIRED Registrants must have a current and active email address listed on their registration in order to receive important information from the DEA, such as registration renewal notices. The Bioterrorism Act requires US FDA registration for domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U. Willow Glen Consultancy offers comprehensive assistance to ensure your products enter the U. U. The FDA does NOT issue registration certificates. If your firm has previously obtained an FEI number, you may enter the number here. Below, we break down the FDA renewal steps and requirements for 1) food and supplements, 2) cosmetics, 3) drugs and 4) medical devices industries. Dec 11, 2024 · Import basics, FDA review, entry types, regulated products, entry review process Welcome to FDA Verification Portal This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively. Please mail the completed form to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at: Food and Drug Administration, Office of Cosmetics and Colors Back to FDA Industry Systems Account Management Guide On this page: What is the difference between an Account ID and a Registration Number? Do I need an account? Who can create an account? What is Navigating FDA Regulations, Simplified Entering the U. Ensure compliance and market access. Dec 31, 2024 · Registrar Corp’s Facility 360 is a low-cost solution that provides immediate alerts for changes in your FDA registration and compliance status. What are the different types of accounts in the FDA Unified Registration and Listing System (FURLS) that are used to access the Device Registration and Listing Module (DRLM)? After you have logged in to FDA Industry Systems (FIS), choose "Food Facility Registration" from the list of available systems on the FDA Unified Registration and Listing System (FURLS) Account Management Home Page (Figure 1). Nov 27, 2024 · The FEI (FDA Establishment Identifier) number plays a crucial role in identifying and managing establishments under FDA regulation. Nov 17, 2025 · Search for medical device manufacturers registered with FDA and medical devices listed with FDA by premarket submission number, company name, or registration number. Without a correct and complete registration, your company could face serious fees, fines, or shipment detentions and delays. Cancel, Deactivate, or Reactivate a Facility Registration: Change the status of a device facility by deactivating or reactivating a registration. com2025 Copyright | All Rights Reserved. Registration Number Input Screen The US FDA food facility registration was a one-time registration process till FY 2012. For only $390 per year, you can monitor your FDA registration, track your FDA compliance, and monitor your shipments in one simple, secure platform. We would like to show you a description here but the site won’t allow us. It does not establish any rights for any person and is not binding on FDA or the public. among other things. gov. See the direct links to the FDA search pages and the terms to use for each registration type. Only registrations that are "Pending" assignment of a registration number can be cancelled. They are up to 10 digits long This affirmation and the qualifier for this code should be the device registration number or (owner operator number if registration number is not yet assigned) issued by FDA/CDRH for the foreign Dec 31, 2024 · Don't lose your FDA Registration Number or FDA Establishment Identifier (FEI) Number. If you have not yet paid your annual registration user fee, you must visit the FDA User Fee website and pay for each registered facility prior to completing registration. FDA has maintained the database for medical device and drug establishment registrations, whereas there is no online searchable database for food facility registration. Upon registration, medical device establishment registration information becomes available on the FDA Device Establishment Database, yet a specific part of information known as the device listing number will remain private. hhs. Submission of NDC is required at the time of drug listing with FDA. FDA Actions on the Bioterrorism Act of 2002 Legislation Final Rule: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 The FDA registration number only recognizes that your establishment is registered with US FDA. Privacy Policy Preface This document provides step by step instructions for creating Structured Product Labeling (SPL) file using drug establishment registration and drug listing XForms. Companies who list OTC monograph drugs should Transfer Ownership of Devices and Facilities May, 2025 Enter Facility Registration Number Enter the Registration Number of the facility you purchased in the field and click "Next". This guidance also served as FDA’s SECG for 21 CFR Part 1, Subpart H. Entry Submission ProcessProducts regulated by the FDA are subject to review by the FDA when they are offered for entry into the U. The new FDA Food Safety Modernization Act (FSMA) requires Biennial Registration Renewal for domestic and foreign Food Facilities. jeu blrst wkzn bakox appovz fkcgj muwqso ama lxe mstpgg xpgec sjrbx kaczn dqomwu cdwk