CAPA Management & FDA Consent Decree

CAPA Management & FDA Consent Decree Support

We help medical device companies design, execute, and sustain effective Corrective and Preventive Action (CAPA) programs — and provide specialized support for organizations navigating the high-stakes demands of an FDA Consent Decree or Warning Letter remediation.

What We Offer

CAPA Management

• CAPA System Design & Optimization — We assess your existing CAPA process against FDA 21 CFR Part 820 and ISO 13485 requirements and implement improvements that ensure problems are identified, investigated, resolved, and prevented systematically.
• Root Cause Analysis (RCA) Facilitation — We lead structured root cause investigations using proven methodologies — including Fishbone/Ishikawa, 5-Why, Fault Tree Analysis, and Is/Is Not — to identify true root causes rather than symptoms.
• CAPA Documentation & Closure — We develop thorough, defensible CAPA records that document problem statements, root causes, corrective actions, effectiveness checks, and closure criteria in a format that satisfies regulatory scrutiny.
• Effectiveness Verification — We design and execute effectiveness check plans to confirm that implemented actions have eliminated the root cause and prevented recurrence — a common area of FDA observation.
• CAPA Backlog Remediation — We triage, prioritize, and close aged or stalled CAPAs, reducing backlog and restoring confidence in your quality system.
• CAPA Training — We train your quality and operational teams on best practices for initiating, investigating, and closing CAPAs to build internal capability and reduce repeat findings.

FDA Consent Decree & Warning Letter Remediation

• Gap Assessment & Remediation Planning — We conduct a thorough assessment against the specific requirements outlined in your Consent Decree or Warning Letter and develop a prioritized, actionable remediation plan with clear ownership and timelines.
• Third-Party Expert Support — We provide the independent expertise and documentation that FDA and court-appointed experts require, helping you demonstrate credible, sustainable corrective action.
• System-Wide Quality Remediation — We lead comprehensive remediation of quality system elements — including design controls, complaint handling, supplier quality, production controls, and records management — to meet the elevated scrutiny of a Consent Decree environment.
• FDA Communication & Submission Support — We assist in preparing responses to FDA, including Written Responses to Warning Letters, status reports to Consent Decree monitors, and certification packages required for resumed operations.
• Sustainable Compliance Infrastructure — We don't just fix the immediate problem — we help you build the quality culture, processes, and metrics needed to maintain compliance long after the Consent Decree is lifted.

Why It Matters

A poorly managed CAPA system is one of the most frequently cited FDA observations — and a leading indicator of deeper quality system failures. For companies under a Consent Decree, the stakes are even higher: operations may be restricted, product may be detained, and reputational damage can be severe. Effective, well-documented remediation is the only path back to full operational status and restored regulatory standing.

Who We Serve

We work with medical device manufacturers facing FDA Warning Letters, Consent Decrees, import alerts, and 483 observations — as well as companies proactively strengthening their CAPA systems before the next inspection.