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FDA CAPA Review Services

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Strengthen Your CAPA System Before the FDA Reviews It

Medical device & pharmaceutical manufacturers know how much emphasis the FDA places on your QMS’s Corrective and Preventive Action (CAPA) system. When FDA Investigators randomly arrive, they often spend a significant portion of the inspection reviewing your CAPAs. Why? They want to see how the organization resolves problems. And the longer they spend, the more likely they are to find systemic problems.

Our clients have experienced Inspectors spend up to an entire week dissecting one single CAPA, examining every detail for completeness, clarity, and the evidence of true effectiveness.

If your CAPAs are found lacking, the consequences can be serious:

  • Form 483 observations
  • Warning Letters
  • Consent decrees or other enforcement actions
  • Reputational damage and costly remediation

At Axeon, we proactively help organizations prevent these painful and costly outcomes. We offer expert CAPA review services which align with the FDA’s stringent requirements and best practices.

 

CAPA Review

Why CAPA Reviews Matter More Than Ever

The corrective and preventive action process is not just a documentation exercise. It is a reflection of how well your quality system identifies, addresses, and prevents systemic issues. When the FDA reviews your CAPAs, they are looking for answers to key questions:

  • Did you identify the real root cause?
  • Was the investigation thorough and objective? – Is there evidence attached to the CAPA demonstrating that the investigation was thorough and objective?
  • Did your corrective action actually solve the problem? – Is there evidence attached to the CAPA demonstrating that the root cause was resolved?
  • Is there a risk of recurrence? – Where is that documented?
  • Did you verify and validate the effectiveness of your actions?

In addition, the FDA’s new Quality Management System Regulation (QMSR), which mostly aligns FDA requirements with ISO 13485, places even greater emphasis on effective corrective action processes. As the agency modernizes its inspection approach, you can expect corrective actions to undergo even more detailed scrutiny, especially around root cause analysis, risk management, and effectiveness checks.

Many companies struggle to meet these expectations, especially when operating under time pressure. Unfortunately, some only realize their corrective actions are insufficient after an inspection has already gone poorly.

That is where we come in.

 

What the FDA Expects in a CAPA

The FDA has become increasingly focused on corrective and preventive action as an indicator of the effectiveness of your quality management system. A single weak corrective action can raise questions about how your organization identifies risk, corrects systemic failures, performs continuous improvements, and maintains control.

Here’s what the FDA typically expects to see in a CAPA:

  1. Clear definition of the issue or nonconformance
  2. Evidence of a well-documented root cause investigation
  3. Corrective actions directly tied to the identified cause
  4. Preventive steps to reduce the likelihood of recurrence
  5. Timely implementation and proper documentation
  6. Effectiveness checks with measurable results

With the introduction of the QMSR, the FDA is expected to more closely align with ISO 13485’s risk-based approach. That means your CAPAs must not only address the issue, but also demonstrate that your decisions are informed by documented risk assessments.

Failure in any of these areas can result in an FDA Observation (finding). In fact, many 483s and Warning Letters cite inadequate corrective and preventive actions systems. Our role is to ensure that your process meets or exceeds these expectations, giving your team peace of mind and conformity to the Regulation during inspections.

 CAPA Review

 

Our CAPA Review Service Includes:

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Documented Evaluation

A detailed review of your corrective action files, including investigations, root cause analysis, corrections, corrective actions, preventive actions, and effectiveness checks.
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FDA Readiness Assessment 

An evaluation of whether your corrective actions would hold up under FDA scrutiny, based on the latest enforcement trends and inspection priorities.
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Gap Analysis

Identification of deficiencies, inconsistencies, or missing elements that could lead to findings.
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Practical Recommendations

Clear, actionable guidance to strengthen your corrective action process and improve individual records.
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Support Post-Inspection

If you have already received 483s or a Warning Letter, we can help you revise corrective actions to address the FDA’s concerns and prevent recurring issues.

 

Who Should Use This Service?

  • ✔ Regulatory professionals responsible for compliance of the QMS and CAPA system
  • ✔ Quality Systems Managers and Coordinators
  • ✔ CAPA System Management
  • ✔ Quality managers who want to ensure their corrective actions and CARs will not raise red flags
  • ✔ Executive leadership seeking to reduce regulatory risk and protect the company’s reputation
  • ✔ Organizations under FDA scrutiny that need to respond quickly and effectively
  • ✔ Any company preparing for an FDA inspection

 

Avoid Pain Later. Take Action Today.

FDA scrutiny of corrective and preventive action systems is increasing, and the best time to find and fix gaps is before the FDA does. Whether you need to validate your current corrective actions or repair those identified during a recent inspection, Axeon’s team of compliance experts is ready to help.

We bring decades of experience with FDA regulations, quality systems, and inspection support. Our approach is straightforward, practical, and tailored to your unique challenges.

Don’t let a single CAPA jeopardize your next inspection. Contact us today to schedule your FDA CAPA review.

 

Request a CAPA Review