FDA Enforcement Response & Remediation
FDA gives written Form 483 responses real weight, and has consistently recommended a substantive response within 15 business days that addresses root cause and systemic correction, not just the specific instance cited. The same logic applies to Warning Letters: FDA evaluates whether the root cause analysis is genuine, not simply whether a reply was filed.
- FDA deficiency and Additional Information (AI) response strategy
An AI letter asks a specific scientific question, and how you answer it, not just what data you attach, determines whether the review closes. We help you respond to what's actually being asked, not what the letter seems to say on a first read.
- Warning Letter response
FDA evaluates Warning Letter responses on whether the root cause analysis is genuine and the CAPA is proportionate, not just whether a response was submitted. We help build both, and draft the response the way a reviewer needs to see it argued.
- FDA Form 483 response
Each 483 observation needs its own response addressing root cause and system-level correction, not just the specific instance cited. We work through the response observation by observation, with the 15-business-day clock in mind.
- Recall strategy, classification planning, and FDA coordination
Recall strategy decisions, and how you characterize the issue to FDA, shape how the agency classifies the recall and how much scrutiny follows. We help think through strategy and coordinate the FDA-facing process.
- Field Safety Corrective Action (FSCA) planning and documentation
FSCAs require coordinated planning across regulatory, quality, and often multiple markets simultaneously. We help structure the plan and the documentation FDA will expect to see.
- Consent Decree advisory and Import Alert response strategy
These represent the more severe end of FDA enforcement, and getting the response strategy right matters more, not less, at this stage. We advise on the regulatory and scientific dimensions of the response, working alongside legal counsel.
- Lifecycle management
Every device change is a fresh regulatory question, whether it needs a new submission, a supplement, or nothing at all. We help evaluate changes against current FDA guidance so lifecycle decisions stay defensible.