Portfolio Rationalization:
Eliminating "Phantom" Listings

The Bottom Line: A manufacturer’s commercial catalog had drifted from their FDA listing footprint, creating liability for products no longer sold and confusion every time someone asked, “Is this still listed?” BRS executed a forensic clean-up to retire obsolete SKUs and align the portfolio with reality, giving leadership a clearer view of what they were truly responsible for—and what could finally be closed out with confidence.

The Situation

Internal stakeholders faced blind spots regarding "what is listed vs. what is sold." Commercial, Quality, and Regulatory all had slightly different answers, and every audit prep meeting surfaced a new spreadsheet. The portfolio contained significant legacy artifacts:

• Phantom Listings: Active FURLS entries for devices discontinued years ago, still visible to FDA as if they were current and creating anxiety every time the inspection calendar came up.
• Fragmented Ownership: No single source of truth between Quality and Sales, which meant long email chains just to answer simple questions like “Is this SKU still on the U.S. market?”
• Code Mismatches: Incorrect Product Codes triggering unnecessary surveillance and internal concern that a future investigator might see “more portfolio” than the company was actually selling.

The BRS Intervention

• Crosswalk Mapping: Reconciled the entire commercial SKU list against the FDA database, sitting with stakeholders to confirm how products were actually sold, labeled, and marketed—not just how they appeared in old systems.
• Controlled Retirement: Documented the rationale for deactivating obsolete records in language that leadership, auditors, and future team members could all understand, turning “mystery data” into a clear, time-stamped decision trail.
• Governance SOP: Implemented a "Listing Owner" role to prevent future drift, with simple triggers for when Sales, RA/QA, or Supply Chain must notify that a change has occurred, so the regulatory record keeps pace with the business.

The Outcome

A Defensible Audit Trail. The client now possesses a "Clean Portfolio" baseline. Any FDA question regarding past or present device status can be answered immediately with traceability, giving executives confidence in front of inspectors and giving internal teams back the time they previously spent reconciling conflicting lists and legacy entries.