What to Expect When Catherine J Laufmann Walks Into Your Facility

When FDA investigator Catherine J Laufmann arrives for an inspection, she brings a detailed, regulation-driven approach that focuses on critical components of your Quality Management System (QMS). Known for her rigorous evaluation of medical device manufacturers, Laufmann consistently identifies patterns of non-compliance that often lead to 483 observations and, in more serious cases, warning letters.

In 2025, with FDA scrutiny on the rise and enforcement tightening around documentation and patient safety, understanding her inspection trends can help your QA team stay ahead of potential violations.

Key Focus Areas in Catherine J Laufmann’s FDA Inspections

FDA inspections led by Catherine Laufmann typically center on three main pillars: Corrective and Preventive Actions (CAPA), Medical Device Reporting (MDR), and Design Controls. Each of these areas plays a critical role in maintaining product quality and regulatory compliance.

1. Corrective and Preventive Actions (CAPA)

In more than 70 percent of her documented inspections, Laufmann has issued observations due to inadequate CAPA procedures. Common findings include:

• Incomplete root cause investigations

• Missing or ineffective verification of corrective actions

• Lack of timely documentation

• CAPA activities not linked back to nonconforming events

In one 2023 inspection report, a firm failed to verify whether a corrective action prevented recurrence. The result? A formal 483 observation that impacted product shipment for months.

2. Medical Device Reporting (MDR)

Reporting failures under MDR regulations has surfaced in many of Laufmann’s inspections. These include:

• Delays in reporting serious adverse events

• Ambiguity in internal definitions of reportable events

• Inconsistent tracking of incidents that may cause harm

In 2024 alone, MDR-related deficiencies accounted for more than 18 percent of all FDA medical device warning letters, a trend that has carried over into 2025. A March 2025 case involved a mid-sized device manufacturer who failed to report three events within the required 30-day window. The result was a public warning letter and reputational damage.

3. Design Controls

Design control violations are another critical area where Laufmann’s observations concentrate. Her inspections have noted:

• Missing or incomplete Design History Files (DHF)

• Lack of verification and validation documentation

• Poorly documented design review processes

• No evidence of risk analysis integration

In a 2025 FDA database update, 42 percent of device-related 483s included design control issues, and Laufmann has been a prominent contributor to this category.

How QA Teams Can Prepare for an Inspection by Catherine J Laufmann

Step 1: Strengthen Complaint Handling Systems

Ensure all complaints are logged, evaluated for MDR applicability, and followed through with appropriate documentation.

• Assign complaint coordinators to review incoming issues daily

• Standardize response timeframes and escalate urgent matters promptly

• Integrate complaint handling with CAPA investigations

Step 2: Build a Robust CAPA Process

Revise your CAPA procedures to ensure they address not only corrective action but also the underlying root cause and long-term effectiveness.

• Use structured root cause tools like 5 Whys or Fishbone diagrams

• Assign timelines and track CAPA milestones

• Verify effectiveness with documented metrics

Step 3: Audit Your Design Control Framework

Conduct a design control gap assessment to verify that all required documentation is in place.

• Review DHFs for each marketed product

• Confirm that verification and validation are documented

• Validate that any design changes are well-documented and traceable

Step 4: Conduct Mock Inspections

Simulate an FDA inspection using internal or external auditors who are familiar with Laufmann’s inspection style. Focus on:

• Documentation readiness

• Process traceability

• Personnel knowledge and training

Step 5: Prepare Your Team

Train all relevant employees on how to respond during inspections. Emphasize:

• Answering only what is asked

• Knowing where the documentation is stored

• Understanding your SOPs thoroughly

Use Tools That Provide Inspector-Specific Intelligence

Platforms like Atlas Compliance can help teams prepare more strategically by showing trends in Catherine J Laufmann’s past inspections, including common citations and focus areas. With access to real-time 483 data and inspection patterns, QA leaders can prioritize the exact areas that matter most to each inspector, not just generic audit prep.

FDA Enforcement Trends in 2025

Recent data from the FDA’s Inspections Database (updated Q2 2025) reveals that:

• Over 1,140 483s have been issued this year in the medical device sector

• Design control violations account for 42% of those

• CAPA deficiencies account for 37%, often overlapping with complaint-handling

• MDR-related findings were noted in 19% of cases

The agency’s tone has shifted toward greater accountability, particularly in post-market surveillance and documentation integrity.

Why This Matters

Inspectors like Catherine J Laufmann are not just looking for boxes to be checked. Their inspections reflect a broader FDA strategy to ensure that companies are not only compliant on paper but also in practice. A single overlooked process, undocumented verification step, or mishandled complaint can trigger a cascade of regulatory consequences.

In 2025, compliance is not just a cost of doing business; it is a brand and business survival strategy. By preparing proactively for the specific areas Laufmann tends to focus on, QA teams can ensure smoother inspections and avoid disruption to operations and market access.

Frequently Asked Questions

Q. What documents should we prepare in advance of an inspection by Catherine J Laufmann?
A. Prepare comprehensive records for:

• Complaint handling

• CAPA investigations

• Design history files (DHF)

• MDR reporting logs

• Training records

• Internal audit reports

Atlas can help you identify which of these areas require the most attention, based on the inspector’s past observations and common industry gaps.

Q. What makes Catherine J Laufmann different from other FDA inspectors?
A. Her inspections are detailed and documentation-heavy. She often focuses on the consistency and accuracy of CAPA systems, MDR reporting, and design control practices. Atlas provides specific insights into Laufmann’s inspection history, so you’re not preparing blindly; you’re preparing with data.

Q. How can we tell if we’re ready for an inspection?
A. You’re likely in good shape if you can:

• Access clean, organized records quickly

• Walk through your SOPs with confidence

• Clearly explain your CAPA and complaint handling workflows

• Show documented improvement linked to past nonconformances

Atlas can validate this readiness by mapping your processes to known inspection patterns and flagging weak spots based on similar company profiles and inspector history.

Q. Are there tools to help with preparation?
A. Yes. Atlas is built specifically to support inspection readiness. It gives you inspector-level intelligence, historical 483 data, warning letter trends, and insights into exactly what someone like Catherine J Laufmann is likely to review, all in one place. Instead of generic prep, Atlas helps you focus where it matters most.

Q. What’s the biggest risk during an inspection?
A. Incomplete documentation and unclear procedures. Inspectors like Laufmann frequently cite companies for inconsistent records or gaps in traceability. Atlas helps mitigate this risk by giving you early visibility into the issues most likely to be raised, so you can fix them before the FDA even walks through the door.