Continuous FDA establishment verification. Catch registration lapses, import alerts, and fee arrears before they disrupt your supply chain.
The problem
A registered FDA facility can be added to an Import Alert list, stop paying required user fees, or let its annual registration lapse, and you might not discover this until your shipment is detained at U.S. Customs.
Traditional supplier qualification catches compliance issues during periodic audits, typically annual or every two years. But what happens between audits? Registration status, import alerts, and fee payments can change any week.
Real-world scenario: the FDA publishes updated Arrears Lists throughout the year. Facilities that fail to pay required fees (such as OMUFA for OTC drug manufacturers) can have their products detained at port, regardless of product quality. By the time you discover the issue, your supply chain is already disrupted.
The solution
Our Facility Compliance Engine runs automated checks against FDA databases weekly, alerting you immediately when a supplier's status changes.
Whether you're sourcing OTC drugs or Class III medical devices, we verify registration, fee payment, and import alert status before every PO, not after goods arrive at customs.
What we monitor
FEI status verification
Does the FEI exist and is the status “Active”? If a medical device or drug manufacturer forgets to renew its annual registration (due December 31st), its products can be detained, just like unpaid fee arrears.
The “Red List”
We check the FEI against the FDA Import Alert database. This includes factories banned for quality issues (bad GMP audits), not just unpaid fees. Critical for Class II/III devices and pharmaceutical components.
Category-specific checks
How it works
Provide the supplier FEI number and commodity category (drug or device).
The system runs a comprehensive compliance verification against all applicable databases.
Weekly automated checks against FDA APIs, plus certificate expiration tracking.
Immediate notification when any supplier's compliance status changes.
Complements your audit program
Automated monitoring doesn't replace on-site audits. It makes them smarter.
Contact us to add automated monitoring to your supplier oversight program.