What is the FDA establishment identifier FEI number?
- What is an FDA Establishment Identification number? An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track GDUFA facility fee payments
- FEI is the Firm Establishment Identifier – FDA database is automatically generates a 10-digit FEI number when a new firm is added. However, firms previously in FIS retained their original 7-digit CFN which in most cases also became their FEI number.
To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. Let’s learn about it.
A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm.
FEI is determined based on the name and address of the company on the business registration or the actual address of the enterprise with evidence. Searching and registering for FEI codes is done at the FEI portal. The development of this portal facilitates the processing of actions within the various divisions of the FDA and ensures that database searches or requests can be conducted as quickly as possible. Not all FEIs are searchable within this portal. FEIs may be associated with information not considered releasable.
An FEI might not be found for several reasons:
- The FEI has personally identifiable information or a law or regulation says the FEI can’t be released.
- The firm at a particular address has not yet been assigned an FEI.
- A firm has changed names or address, making the search for the FEI more difficult.
If you cannot search, you must contact the FDA, provide the necessary information and relevant evidence to meet the intended use, and they will send you the results.
FEI is mandatory information required to register a Cosmetic establishment. Please contact us if you need assistance.
