In today’s highly regulated global market, US FDA compliance is no longer optional for companies dealing in foods, drugs, cosmetics, medical products, and related categories. Whether you are a manufacturer, exporter, private label brand, contract packer, Amazon seller, or online marketplace vendor, one term you will encounter repeatedly is the US FDA FEI Number.
This article is a complete business-focused guide explaining the FDA Establishment Identifier (FEI) Number, its role in FDA Registration and Listing, and how it applies to CDER, Amazon compliance, and online salesfor Foods, Drugs, and Cosmetics.
What Is a US FDA FEI Number?
The FDA Establishment Identifier (FEI) Number is a unique numeric identifier assigned by the U.S. Food and Drug Administration to each regulated manufacturing, processing, packing, or holding facility.
Unlike certificates that expire, the FEI number is permanent and is used internally by the FDA to:
- Identify regulated facilities
- Track inspections and compliance history
- Link establishments to FDA Registration & Product Listings
- Monitor recalls, warning letters, and enforcement actions
Important:
An FEI number is not optional once your facility is recognized under FDA regulations.
Why the FDA FEI Number Is Critically Important for Businesses
The FEI number acts as the digital identity of your facility within the FDA ecosystem. Without it, businesses often face:
- Import detentions at US ports
- Amazon seller account suspension
- Product listing rejection
- Delays in CDER submissions
- FDA inspection non-recognition
Key Business Benefits of Having an FEI Number
- Faster FDA interactions
- Smooth product listing and renewals
- Amazon and marketplace compliance
- Trust with US buyers and distributors
- Reduced regulatory risk
FDA Establishment Registration vs FEI Number (Clear Difference)
| Aspect | FDA Registration | FEI Number |
|---|---|---|
| Purpose | Legal compliance requirement | Permanent facility identifier |
| Renewal | Annual / Biennial | No renewal |
| Issued By | FDA | FDA |
| Visibility | Public (some databases) | Internal FDA system |
| Required For | Foods, Drugs, Cosmetics, Medical Products | All FDA-regulated facilities |
Registration creates the record; FEI assigns the identity.
FDA FEI Number for CDER (Drugs & Pharmaceuticals)
For pharmaceutical companies, the FEI number is mandatory when dealing with Center for Drug Evaluation and Research (CDER).
FEI Is Required For:
- Drug Establishment Registration
- Drug Product Listing (SPL)
- ANDA / NDA / DMF references
- GMP inspections
- Import/export clearance
Any API manufacturer, formulation unit, repacker, relabeler, or contract manufacturer supplying to the US must have a valid FEI number linked to their registration.
FDA FEI Number for Amazon & Online Sellers
Amazon has significantly tightened compliance checks for FDA-regulated products. Sellers offering foods, cosmetics, OTC drugs, supplements, and personal care products are frequently asked for:
- FDA Establishment Registration
- FEI Number confirmation
- US FDA Agent details
- Product listing proof
Why Amazon Requests FEI Numbers
- Verification of FDA-registered facility
- Risk mitigation against counterfeit or unsafe products
- Compliance with US federal regulations
Without a valid FEI number, sellers may experience:
- Listing removal
- Account suspension
- Funds being held
FDA FEI Number for Food Facilities (FSMA Compliance)
Food facilities manufacturing or exporting to the US must comply with FDA Food Facility Registration under FSMA.
FEI Applies To:
- Food manufacturers
- Processors
- Packers
- Warehouses
- Cold storage facilities
Once registered, the FDA assigns an FEI number, which is then used for:
- Prior Notice filings
- Import screening
- FDA inspections
- Compliance verification
FDA FEI Number for Cosmetics (MoCRA Compliance)
With the implementation of MoCRA (Modernization of Cosmetics Regulation Act), FDA oversight of cosmetics has expanded.
FEI Is Required For:
- Cosmetic manufacturing facilities
- Contract manufacturers
- Private label cosmetic plants
Although cosmetics do not require “approval,” facility registration and FEI assignment are now essential for:
- Facility identification
- Safety substantiation
- Adverse event tracking
Who Needs an FDA FEI Number?
You need an FEI number if you are:
- Manufacturer (India, USA, EU, China, etc.)
- Exporter to the United States
- Amazon / eCommerce seller of FDA-regulated products
- Contract manufacturer or third-party packer
- Private label brand owner
- Warehouse or holding facility
How Is an FDA FEI Number Assigned?
The FDA assigns an FEI number when:
- A new facility registers with the FDA
- FDA verifies establishment details
- An inspection is scheduled or conducted
- Existing records are matched or created
You cannot “apply” for an FEI number separately. It is generated as part of the FDA’s internal establishment identification process.
Common Mistakes Businesses Make With FEI Numbers
- Assuming FEI = Registration Certificate
- Using incorrect or duplicate facility details
- Mismatch between FDA registration and Amazon documents
- Not updating address or ownership changes
- Not appointing a US FDA Agent
These errors often lead to import alerts, Amazon takedowns, and regulatory delays.
Role of US FDA Agent in FEI & Registration
Foreign establishments must appoint a US FDA Agent to:
- Communicate with FDA on their behalf
- Receive inspection notices
- Support compliance actions
- Coordinate during emergencies
The FDA Agent plays a critical role in FEI number validation and maintenance.
FDA FEI Number Verification & Confidentiality
- FEI numbers are not fully public
- Only limited verification is possible
- FDA uses FEI internally for enforcement and tracking
Because of this, professional handling is essential to avoid misrepresentation or incorrect filings.
Why Professional FDA Registration Support Matters from XPRO America
FDA systems like:
- FURLS
- CDER Direct
- SPL submission portals
are complex and unforgiving of errors. A single mistake can delay compliance by months.
Professional Support Ensures:
- Correct establishment classification
- Accurate facility mapping
- Clean FEI assignment
- Amazon-ready documentation
- End-to-end FDA compliance
Business Impact of a Proper FDA FEI Setup
- Faster US market entry
- Smooth Amazon onboarding
- Reduced regulatory risk
- Higher buyer confidence
- Scalable global exports
Final Thoughts
The US FDA FEI Number is not just a regulatory formality—it is the foundation of your FDA compliance identity. Whether you operate in Foods, Drugs, Cosmetics, CDER-regulated products, or Amazon marketplaces, having a properly registered establishment with a valid FEI number is essential for sustainable business growth in the US market.
If your goal is zero delays, zero rejections, and maximum compliance confidence, FEI-related registration must be handled strategically and professionally.
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