FDA FEI Establishment Identification Review and Request Support

Support for reconciling the FDA Establishment Identifier, legal establishment name and address, checking for an existing FEI and preparing consistent facility identity data for applicable FDA programs.

Service overview

The FDA Establishment Identifier is used by FDA to identify and track regulated establishments across registration, listing, inspection and reporting programs. An FEI is not product certification or market approval and does not replace food-facility, medical-device, drug-establishment or cosmetic-facility registration. SCS Testing helps avoid duplicate requests and inconsistent legal names or addresses and connects FEI information to the applicable program.

Applicable products or businesses

• Food, cosmetic, medical-device, drug or other regulated establishments that must confirm/provide an FEI
• Businesses with changes to legal name, address or ownership
• Projects facing FEI mismatch, duplicate establishment or missing-record issues

Target market

• U.S. FDA-regulated programs

Regulatory authority

• U.S. Food and Drug Administration

Regulations, directives and standards

• Current program-specific requirements for establishment identity and FEI use
• FDA FEI search/request channels and applicable guidance
• Data-consistency requirements in the relevant registration, listing or reporting system

Service scope

• Comparison of legal name, address and historical records
• Existing FEI search and potential duplicate analysis
• FEI request/reconciliation data preparation
• Alignment with the relevant FDA registration, listing or reporting project

Service process

• Collect legal entity, physical address, trade names and historical FDA information
• Search for possible FEIs and establishment records
• Determine whether to reuse, update, clarify or request a new FEI
• Prepare authorised-contact and establishment evidence
• Use the confirmed FEI in the applicable program and retain supporting evidence

Information required

• Business licence or equivalent legal-entity evidence
• Physical/mailing addresses, trade names and historical names
• Contacts, authorization and establishment activities
• Existing FEI, registration number, FDA correspondence or system evidence
• Related sites, parent/subsidiary relationships and ownership-change explanation

## Reports, certificates or registration outcomes Outputs are an FEI search/reconciliation record, data-gap list and applicable request support. FDA manages FEI assignment; an FEI does not mean company or product approval and does not complete a program-specific registration or listing.

Factors affecting timing

Timing depends on legal-name/address consistency, historical duplicate records, authorization evidence and FDA response. A new FEI cannot be promised before the existing-record review.

Common compliance risks

• Requesting multiple FEIs for the same establishment
• Confusing an office, warehouse and manufacturing site
• Using inconsistent legal names or addresses across FDA programs
• Promoting an FEI as a registration certificate or product approval

Related services

• FDA food facility registration
• FDA medical-device registration and listing
• FDA drug establishment registration and listing

Information for an initial assessment

Provide the product name, model, intended use, target market, bill of materials and available reports so that the applicable route and evidence gaps can be assessed.