An FEI is an FDA system generated unique number used to identify a firm, establishment, or facility involved in manufacturing, packing and distribution of FDA-regulated products. The FEI helps the FDA track inspections, facility registrations, and other regulatory activities.
FEI is different from DUNS or EIN.
FEI for Drugs
- Both US and foreign drug manufacturing or processing facility must register with the FDA and is assigned an FEI after registration.
- FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.
FEI for Medical Devices
- Manufacturers, contract manufacturers, foreign exporters, initial importers, relabelers, repackagers must register with the FDA and are assigned an FEI upon registration.
- FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.
FEI for Food
- The FEI helps the FDA with communication, inspection planning, and tracking facility-related activities during food safety investigations.
- The FEI is distinct from the food facility registration number, which is an 11-digit FDA-assigned number assigned after registration.
FEI for Cosmetics
- The FEI is the required facility registration number used by the FDA to identify cosmetic product facilities in its database.
- Obtaining an FEI is the first step toward registering a cosmetic facility with the FDA. You must have an FEI before submitting a facility registration.
- The FEI links the facility registration to product listing submissions, which must include the FEI of each facility manufacturing or processing the cosmetic products.
- The FEI number does not expire. Once assigned, the FEI remains valid and does not require renewal.
- The FEI is different from cosmetic facility registration, which must be renewed biennially to maintain compliance.
Liberty Management Group Ltd can help facilities with FDA Regulations for all above product categories.
Namrata
Regulatory Consultant