Unlocking the FEI Number: Why Every FDA-Regulated Facility Needs One

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.

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🔍 How to Look Up an FEI Number?

You can look up or verify a facility’s FEI number using the FDA’s FEI Search Portal: https://feiportal.fda.gov

You can search by name, address, DUNS number, or registration number.

✅ Who Needs an FEI Number?

Assigned to any facility that:

Registers with the FDA (e.g., drug establishments, food facilities under FSMA, etc.)
Has undergone or is expected to undergo an FDA inspection
Participates in FDA-regulated activities

Includes facilities involved in:

Prescription and over-the-counter drugs
Biologics (e.g., vaccines, cell therapies)
Medical devices
Food and dietary supplements
Veterinary products
Cosmetics (voluntary)

Includes facilities involved in the following activities:

Manufacturing, packaging, or labeling drug substances or products (including intermediates, APIs, and finished doses).
Testing drug substances or products (e.g., stability testing, release testing).
Storing drug substances, in-process materials, or commercial products under quarantine.
Combination product manufacturing (including device constituent part facilities, per 21 CFR 820.30).

📌Important Notes

Applicable to both domestic facilities under 21 CFR 207.21(a) (must register within 5 days of starting operations) and foreign facilities under 21 CFR 207.21(b) (must register before importing drugs into the U.S.)
Foreign Facilities must designate a U.S. agent (21 CFR 1.227) and register 90 days before exporting to the U.S.
Registration and FEI numbers are still mandatory for operational facilities not impacting the commercial control strategy (e.g., some R&D sites).

🛠️ How Is an FEI Number Assigned?

📌 Key Considerations

Once assigned, it stays with that facility’s physical location unless it undergoes a major operational change.
FEI numbers are facility specific. Do not request a new number if the facility already has one (e.g., from prior registration for other commodities).
Do not delay submitting applications due to pending FEI numbers. Request the FEI as early as possible and include it in subsequent amendments if needed.

Future-Proofing Compliance: FEI and Digital Transformation

Picture2 1 The FDA is integrating artificial intelligence and predictive analytics into its compliance systems. FEI data is being used to:

Predict inspection priorities
Flag compliance risk across global supply chains
Map quality performance by facility cluster

Recent Development: The FDA’s Remote Regulatory Assessment (RRA) Program amid the COVID-19 pandemic, the FDA began conducting virtual inspections using FEI as a primary identifier. Facilities were reviewed remotely based on historical FEI-linked compliance data.

What It All Means:

FEI is more than a number—it’s your gateway to regulatory trust
Transparency, accuracy, and consistency are non-negotiables
Digital-savvy compliance is now the norm, not the exception

Obtaining an FEI number is a foundational step for FDA-regulated facilities, requiring meticulous preparation and adherence to evolving standards. By following the structured process, leveraging FDA resources, and staying updated on regulatory changes, applicants can streamline their registration process and ensure timely review of their applications. Businesses can ensure compliance, avoid disruptions, and maintain access to the U.S. market.

Pharma Focus