Get held product shipping again, and keep it shipping.
An FDA 483, a product hold or a failed validation can stop shipments overnight. The technical fix matters, but so does running the recovery as a program: clear pathways, named owners, daily management and executives who can see exactly where revenue is coming back.
Where I help
- Turning FDA 483 observations into workstreams with owners, dates and realistic commitments
- Held-product recovery and disposition
- Sterilization and process revalidation pathways, including ethylene oxide half-cycle studies and biological indicator work
- Coordinating Quality, Regulatory, microbiology, Commercial, external laboratories and contract sterilizers
- Executive steering committees, daily management and CEO-level reporting
- SKU and revenue impact tracking, so leadership knows what is at stake and what has been recovered
How I run a remediation
I split the problem into parallel pathways: fast recovery of what is already held, a durable fix for ongoing production, and a longer-term route to resilience. That way the business is not waiting on the slowest path. Shared prerequisites are managed once, each pathway has its own plan, and progress is reported in revenue as well as milestones.
Results
In a sterilization remediation, this approach recovered roughly $10M in one-time revenue and enabled $5–10M in annual revenue. Read the case study. In a separate program, roughly $300M in product revenue held over a new ISO labeling requirement was fully restored.
Who this is for
Medical device and life-science manufacturers facing an FDA 483, a ship hold, escalation risk or a validation gap that needs to be closed quickly and defensibly.
Common questions
How quickly do we need to respond to an FDA 483?
FDA generally considers responses received within 15 business days when deciding on next steps, so planning should start the day the inspection closes. See what to do in the first 30 days after a 483.
Do you replace our Quality or Regulatory team?
No. I lead the program around your experts so they can focus on the technical work, and I make sure decisions, dependencies and escalations do not stall.
