The FEI (FDA Establishment Identifier) number plays a crucial role in identifying and managing establishments under FDA regulation. 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. In this article, UCC will cover the key aspects of the FEI number, including its definition, role, registration process, and, importantly, the differences between the FEI and DUNS numbers.
1. Overview of FEI Number
1.1. Definition
The FEI number is a unique 10-digit identifier assigned by the FDA to establishments regulated by the agency. Specifically, it is used to track inspections at facilities and, in addition, manage facility fees under the Generic Drug User Fee Amendments (GDUFA) program. Therefore, this number is essential for maintaining compliance with FDA regulations.
1.2. Role
The FEI number serves several important purposes:
- Identification of Businesses: It acts as a unique identifier for businesses, allowing the FDA to track each facility efficiently. This is particularly vital when dealing with thousands of establishments worldwide.
- Inspection Management: The FEI helps the FDA monitor inspection histories and assess compliance with safety and quality regulations.
- Fee and Administrative Management: Businesses involved in the production of generic drugs require an FEI for paying fees under GDUFA. Additionally, it is used in the licensing and registration processes for cosmetics and other FDA-regulated activities.
- Transparency and Information Retrieval: The FEI number is a “key” that enables the FDA to quickly access information about an establishment. In particular, it provides details such as its location, inspection history, and safety-related issues. As a result, the FEI number plays a crucial role in ensuring efficient and accurate regulatory oversight.
2. How to Register for an FEI Number
2.1. Who Needs an FEI Number?
According to Section 607(a)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, any individual or organization owning or operating a facility that manufactures or processes cosmetics for distribution in the United States must register their establishment. Exceptions may apply as outlined by the FDA.
2.2. Registration Process
To check if you already have an FEI number:
- Step 1: Access the FEI Portal: First, visit the FEI Portal website.
- Step 2: Login to Your Account: Then, use your existing account credentials to log into the system.
- Step 3: Search for Your Information: After that, enter details about your business or FEI number to check.
- Step 4: View Results: Finally, the system will display the corresponding information.
If your facility does not yet have an FEI number, you should contact the FDA via email at feiportal@fda.hhs.gov. Kindly ensure that the following details are included:
- Legal name of the company
- Any other trade names or business aliases under which the company operates (doing business as)
- The full address of the facility, including street, city, state, and postal code
- The mailing address, if it differs from the physical address
- The name and contact information of the designated person at the facility
- List of activities conducted at the facility (e.g., such as drug manufacturing, food packaging, and other related activities.)
- Registration numbers related to other FDA centers (if applicable)
- Previous names or addresses of the facility (if any)
3. FEI vs. DUNS
3.1. FDA DUNS (Data Universal Numbering System)
- Purpose: The DUNS number, provided by Dun & Bradstreet (D&B), is a unique identifier used to track businesses in D&B’s database.
- Application: It is recognized by the FDA for food facility registration (FFR) and can be used for other purposes, such as credit assessment and business data management.
- Portal Access: The DUNS portal allows users to search for business information in the D&B database and retrieve their DUNS number.
- Access: DUNS Portal
3.2. FDA FEI Number
- Purpose: The FEI number is a unique identifier assigned by the FDA to establishments that manufacture, process, or store cosmetics, food, drugs, and medical devices. Specifically, it helps the FDA track and manage compliance for facilities in these industries. Consequently, the FEI number plays a vital role in regulatory processes.
- Application: FEI is crucial for FDA registration of cosmetics facilities and helps the FDA track inspections and associated fees.
- Portal Access: The FEI portal allows users to search and verify an establishment’s FEI, linking it to a specific address or company within the FDA’s database.
- Access: FEI Portal
In summary, the FEI number is essential for businesses under FDA regulation. Understanding its role in compliance processes can benefit your business, whether registering a new facility or checking your status. While both FEI and DUNS numbers serve as business identifiers, FEI is primarily for FDA-related needs. If you have any questions about facility registration or meeting FDA requirements, don’t hesitate to contact UCC.
For more information: MoCRA Cosmetic: Innovating Cosmetic Regulations
