Recent FDA inspection data paints a clear picture: deficiencies in Corrective and Preventive Action (CAPA) systems remain among the top reasons medical device sites receive citations and warning letters. We analyzed Redica Systems data and found that out of 72 inspected sites that had received warning letters between 2020 – 2024, 59 (82%) had been cited for CAPA, and many also struggled with related areas like complaint handling and nonconforming product controls (Figure 1).

The takeaway is simple: organizations need to rethink their approach to CAPA. A well-designed system isn’t just about meeting compliance requirements—it’s about building an efficient, scalable process that solves problems effectively and prevents them from recurring. By adopting strategies like a two-tier CAPA system, improving problem statements, and focusing on risk-based prioritization, companies can address these issues head-on while fostering a culture of quality improvement.

Why CAPA Systems Are Under the Microscope

From 2020 to 2024, FDA inspections have highlighted pervasive challenges in CAPA management. In the Redica Systems screenshot below, the data shows that:

Of inspections that resulted in an escalation to a warning letter or OAI, 820.100 CAPA was cited 50 times (85% of instances in the dataset) for being inadequate.
820.198 complaint procedures resulted in an additional 38 citations (73% of instances).
Related areas like nonconforming product controls (820.90) and MDR reporting (803.17) were also frequently flagged.
This pattern underscores the importance of CAPA systems as the backbone of compliance. A strong CAPA program can not only address these issues but also prevent related failures in complaint handling, nonconforming product controls, and adverse event reporting.

The message is clear: improving CAPA isn’t just a best practice—it’s critical for avoiding serious regulatory inspectional issues and driving operational excellence.

Figure 1 | 21 CFR 820.100 – CAPA is the most cited issue in 483s that are associated with Warning Letters.

Figure 2 | Inspections that resulted in 483s with CAPA cited are more likely to escalate to OAI or Warning letters.

How to Strengthen Your CAPA System

CAPA is all about identifying problems, understanding their root causes, and putting fixes in place to prevent them from coming back. Sounds simple enough, right? But here’s where things go wrong:

Problem statements are often vague, which wastes time chasing the wrong issues.
Too many minor issues get escalated to full CAPA investigations.
Teams get buried under CAPAs that feel bureaucratic and hard to tackle.

When this happens, it’s easy for CAPA to lose its purpose—and for teams to lose interest.

The good news is that there are practical, proven strategies to make your CAPA program more effective while reducing its complexity. Here’s how:

1. Start with Better Problem Statements

If your problem statement doesn’t clearly explain the issue, it’s like trying to solve a puzzle without all the pieces. Make sure every problem statement answers:

What happened?
When and where did it happen?
How much was affected?
What are the consequences?

Example:

Weak: “The machine is broken.”
Strong: “The XYZ machine failed to maintain temperature control, causing three batches to fall out of spec on 3/15/2023.”

2. Stop Escalating Everything

Not every hiccup needs to go through a full CAPA process. Use a risk-based approach to decide when to escalate:

Is it a one-off issue or part of a pattern?
Could it harm patients or violate regulations and require a recall?

Can it be quickly resolved, or does it require more?

3. Assess Risk Thoughtfully

Take a close look at the severity and likelihood of each issue:

How bad could it be if it happens again?
How likely is it to recur?

Tools like risk assessment tables or Failure Modes and Effects Analysis (FMEA) can help you prioritize CAPAs effectively.

4. Implement a Two-Tier CAPA System That Uses Risk-Based Prioritization

Armed with your strong problem statement, the easiest way to incorporate smart escalation and risk assessment is by adopting a two-tier system. It’s like dividing your laundry into lights and darks—it’s just more efficient. Not every issue requires the same level of response. Applying a risk-based approach ensures resources are allocated where they’re needed most:

Low Risk: Address through quick fixes at Tier 1.
High Risk: Escalate to Tier 2, with a full investigation and root cause analysis.

By focusing on severity and likelihood, you can prevent low-priority items from consuming valuable time while ensuring critical issues are not overlooked. Here’s how it works:

Tier 1: For simple, straightforward issues that can be fixed quickly without a deep investigation. These can be resolved quickly with less documentation and effort, ensuring smaller, less risky problems don’t pile up.
Tier 2: For complex, systemic issues that need more time, analysis, and resources to resolve. These are tackled with a more structured and thorough approach.

Why It Works or….What’s in it for you:

Efficiency: Minor issues are resolved quickly without bogging down the system, reducing the number of CAPAs clogging it.
Focus: Your team can spend time and energy on the big, important issues, thus preventing teams from feeling overwhelmed.
Motivation: Encourages fast resolution of low-risk issues while prioritizing resources for critical challenges. Solving quick, easy Tier 1 issues is satisfying, while working on Tier 2 problems provides opportunities for learning and recognition.

As a bonus, the methodology aligns with the FDA’s risk-based approach to quality management, reducing the likelihood of citations for inadequate procedures. You can check out their take on it here: Make CAPA Cool White Paper.

Case in Point: How a Two-Tier System Works in Action

Example 1: Contaminated Heat Exchangers

The Problem: Heat exchangers showed fungal contamination across multiple lots.
Response: As a high-risk, systemic issue, it was escalated to Tier 2 for a deep investigation. The solution included updating cleaning protocols, completing a new process validation, and retraining staff.

Example 2: Gown Seal Failures

The Problem: Two gowns failed seal integrity testing over six months.
Response: Since this was a minor, low-risk issue with no patient impact, it was handled as a Tier 1 CAPA with a quick process adjustment. This resolved the sealing inconsistency during manufacturing.

The Case for Taking Action Now

The data from FDA inspections leaves no room for complacency. Inadequate CAPA systems don’t just lead to warning letters—they reflect deeper issues in quality management that can jeopardize patient safety and your organization’s reputation. CAPA systems are a cornerstone of compliance and quality management, but they don’t have to be burdensome. The FDA inspection data shows the consequences of poorly managed CAPA programs, but it also offers a clear path forward. By implementing practical strategies like a two-tier system and focusing on clarity and prioritization, your organization can turn CAPA from a regulatory requirement into a powerful tool for continuous improvement.

What You Can Do:

Start by assessing your current CAPA process for areas of inefficiency or overcomplication.
Train your teams on writing strong problem statements and using a risk-based approach.
Implement a two-tier system to handle issues more effectively while reducing bottlenecks.

Don’t wait until an FDA inspection highlights gaps in your CAPA system—act now to build a process that works for your team, your products, and your patients.

References

MDIC White Paper: Make CAPA Cool White Paper
GHTF Guidance Document (2010): CAPA Guidance

About the Author

Jackie Torfin brings 34 years of experience in quality systems, regulatory affairs, and quality assurance. She specializes in designing and improving CAPA programs to meet regulatory requirements and enhance operational efficiency. She can be contacted at Jackie.Torfin@QLeaRAdvisors.com.