FDA Establishment Identifier (FEI)

The FDA Establishment Identifier (FEI) is a unique number assigned by the FDA to identify each physical establishment that manufactures, processes, packs, or holds FDA-regulated products, including cosmetics. Every facility that must register under MoCRA needs an FEI number.

If a facility does not already have an FEI number (for example, from previous drug or device registration), one must be requested from the FDA before submitting a cosmetic facility registration. FEI numbers can be requested through the FDA's FEI Portal or by contacting the FDA directly.

Each physical location receives its own FEI number — a company with multiple manufacturing sites will have a separate FEI for each. The FEI is tied to the physical address, not to the company name, so the same FEI persists even if the facility changes ownership.

The FEI number is used in facility registration submissions, product listing submissions (to identify the manufacturing site), and by FDA inspectors to identify and track facilities. It is distinct from other FDA identifiers such as the DUNS number or NDC Labeler Code.