Stabilizing Market Access:
The 48-Hour Recovery Protocol

The Bottom Line: A non-U.S. manufacturer faced imminent import risks due to missing establishment data. BRS executed an emergency takeover, re-baselined the FURLS record, and locked in a defensible compliance strategy—all in under two business days. For the client’s leadership team, it meant avoiding a public disruption of supply, calming internal pressure from sales and logistics, and knowing that someone was actively steering the situation instead of simply forwarding FDA emails.

The Situation

The client’s previous U.S. Agent had failed to renew their establishment registration, leaving their FDA status “Inactive.” The issue came to light only when the commercial team realized that key shipments were already in transit. With production slots booked and customers waiting, the regulatory problem was no longer a theoretical risk—it was a real threat to revenue and relationships. With shipments on the water, the client faced:

• Immediate risk of Port of Entry detention, with distributors already committed to delivery dates.
• Loss of visibility into their own FURLS account, creating internal anxiety and finger-pointing.
• Inaccurate device listing data triggering FDA red flags and undermining confidence in their future audits.
• A leadership team asking for clear answers and a concrete plan within hours—not weeks.

The BRS Intervention

• Hour 0-4: Secured legal authorization and regained FURLS access, guiding the client step-by-step through designations and authorizations so executives understood exactly what they were signing and why.
• Hour 4-12: Audited 100% of device listings against the shipping manifest, prioritizing SKUs tied to in-transit orders and flagging any codes that could create confusion at the border.
• Hour 24: Reactivated establishment registration and confirmed status directly in the system, giving the client a concrete, screen-level view they could share with internal stakeholders and their logistics partner.
• Hour 48: Issued a new “Certificate of U.S. Agent Designation” and documented a simple, repeatable renewal rhythm so this scenario would not return in the next cycle.

The Outcome

Zero shipment delays. The client moved from “At Risk” to “Audit Ready” in less than two business days. Their commercial team kept promised delivery dates, their RA lead regained control of the FDA footprint, and the executive sponsor walked away with a clear map of “who owns what” going forward. Most importantly, the issue became a one-time story about resilience—not an ongoing compliance fire drill.