Whether you’re manufacturing life-saving drugs or packaging dietary supplements, there’s one unique 10-digit number that could make or break your regulatory journey: the FDA’s Facility Establishment Identification (FEI) number.
The FEI is not a marketing label or a stamp of approval. It’s a vital, behind-the-scenes tool that allows the FDA to track inspections, monitor compliance, and take enforcement actions when necessary. Think of it as your facility’s fingerprint in the FDA’s vast regulatory system.
🧩 What Is It Used For?
The FDA primarily uses the FEI number for:
- Inspection Tracking: All inspections are associated with an FEI.
- Compliance Monitoring: Helps in identifying repeat violations and compliance trends.
- Regulatory Correspondence: Often required in warning letters, recalls, and import alerts.
- User Fee Programs: Required under programs like GDUFA (Generic Drug User Fee Amendments), BSUFA (Biosimilar User Fee Act), etc.