AUTOMATED COMPLIANCE MONITORING
Continuous FDA establishment verification. Catch registration lapses, import alerts, and fee arrears before they disrupt your supply chain.
THE PROBLEM
Your supplier's compliance status can change overnight
A registered FDA facility can be added to an Import Alert list, stop paying required user fees, or let their annual registration lapse—and you might not discover this until your shipment is detained at U.S. Customs.
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.
Traditional supplier qualification catches compliance issues during periodic audits—typically annual or biannual. But what happens between audits? Registration status, import alerts, and fee payments can change any week.
THE SOLUTION
Automated checks against FDA databases—weekly, not annually
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
Universal checks that apply to all regulated suppliers
FDA ESTABLISHMENT REGISTRATION
FEI Status Verification
Does the FEI exist and is the status "Active"? If a medical device or drug manufacturer forgets to renew their annual registration (due December 31st), their products can be detained—just like unpaid fee arrears.
FDA IMPORT ALERTS
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
Additional monitoring based on your supplier category
DRUG SUPPLIERS (OTC MONOGRAPH)
- OMUFA Fee Status Verify facility has paid required Over-the-Counter Monograph User Fee Act fees. Unpaid fees result in automatic detention.
- cGMP Audit History Review recent FDA inspection outcomes (483s, Warning Letters) that may indicate compliance risks.
MEDICAL DEVICE SUPPLIERS
- Device Listing Verification Confirm the facility lists the specific device (Product Code) they are selling you. Unlisted devices are misbranded.
- ISO 13485 Certificate Tracking Upload certificates, extract expiration dates, and receive 90-day warnings before certificates expire.
- 510(k)/PMA Linkage For Class II/III, verify the manufacturer is the owner or contract manufacturer listed on the 510(k) clearance.
HOW IT WORKS
Four steps to continuous compliance visibility
1
ONBOARD
Provide supplier FEI number and commodity category (Drug or Device)
2
INITIAL CHECK
System runs comprehensive compliance verification against all applicable databases
3
CONTINUOUS MONITORING
Weekly automated checks against FDA APIs and certificate expiration tracking
4
INSTANT ALERTS
Immediate notification when any supplier's compliance status changes
COMPLEMENTS YOUR AUDIT PROGRAM
Automated monitoring makes manual audits smarter
Automated monitoring doesn't replace on-site audits—it makes them smarter.
Between Audits
- Continuous visibility into compliance status
- Catch issues before they impact shipments
- Document due diligence for regulators
Prioritize Audits
- Flag suppliers with status changes for urgent audits
- Pre-screen new suppliers before committing resources
- Risk-based audit scheduling
STOP COMPLIANCE SURPRISES BEFORE THEY START
Contact us to add automated monitoring to your supplier oversight program