How to avoid seeing your name published in an FDA warning letter

Date: June 25th, 1:00 - 2:30 pm ET
Presenter: Mike Drues 

Getting a device to market is a significant achievement. But market clearance or approval is the beginning of a new set of regulatory obligations, not the end of FDA scrutiny. Many companies discover this the hard way.

483 observations, warning letters, and consent decrees are more common than most post-market teams expect, and the reasons behind them are often avoidable. The patterns repeat. Most post-market quality failures are not random. They are predictable, and they tend to share recognizable warning signs that a structured quality system would have surfaced earlier.

This webinar uses a case study approach to examine the most common reasons medical device companies run into post-market regulatory trouble. Two examples from April 2026 illustrate how quickly the landscape is shifting:

FDA issued its first warning letter citing GMP violations related to the use of AI in manufacturing. The agency cited a manufacturer for using AI to generate product specifications, procedures, and master production or control records. When FDA raised the absence of process validation, the company stated it was unaware of the requirement because the AI agent had not flagged it. FDA is now considering publishing employee names alongside company names in future warning letters.

Separately, FDA reported that more than 2,200 manufacturers failed to meet clinical trial submission requirements, with 29.6% of required trial results missing from ClinicalTrials.gov.

These are not edge cases. They reflect predictable gaps in post-market quality systems that most teams do not identify until a regulator does.

In this webinar, participants will learn practical approaches to avoiding the most common post-market quality failures, grounded in real examples from FDA enforcement activity.

You will learn:

• The most common patterns behind FDA 483 observations and warning letters in post-market operations
• Why most post-market quality failures are predictable, and how to identify the warning signs early
• What the 2026 AI and GMP warning letter means for manufacturers incorporating AI into their processes
• How to build a post-market quality system that supports consistent compliance, not just audit readiness