No one working in the medical device industry is a stranger to FDA Warning Letters. Every month, FDA compiles a list of infractions from the last 30 days, routinely naming major companies like Abbott, Boston Scientific, and Medtronic.
At a panel at MDM West in Anaheim, titled “Most Common Problems Found During FDA Inspections and What Should We Do to Prevent Them,” Michael Drues, President at Vascular Sciences, broke down the most common reasons medical device companies get hit with infractions. And according to Drues, there has been very little change in these statistics over the last 20 years.
“This list has been the same for nearly 20 years. What does it say about the industry, and what does it say about people in the industry? I get frustrated when I see people making the same mistake over and over again,” Drues told the audience. “That is Einstein’s definition of insanity. Practice does not make perfect, perfect practice makes perfect. If you practice making mistakes, you’ll get really good at making the same mistakes over and over and over again.”
Drues told the audience that the first thing manufacturers need to do is an in depth evaluation of their QMS. Drues commonly works as a Professional contributor to trials involving medical device injuries, and he noted the first place he looks when building a case is a company’s own QMS. “Don’t expect everything to be right just because you can tick QMS, and that that it how it works,” he told the audience. “When companies get sued, they argue that their QMS ticks all of the boxes. The best advice I can give during my consulting work comes from working product liability cases.”
10 most common reasons for FDA-483 observations and warning letters
Drues shared data with the audience, breaking down the 10 most common reasons for 483 observations.
“CAPA’s are at the top, and have been for awhile,” he said. “More companies get Warning Letters because of CAPAs than any other reasons. It has been this way for at least the last 17 years.” CAPA’s account for 12.42% of all FDA-483 observations, followed by Design Controls (12.32%) and complaints (10.61%). Those three (3) factors account for over a third (1/3) of observations, and according to Drues, this has been the case for nearly 20 years.
Rounding out the top 10 list include purchasing controls, process validation, medical device reporting, nonconforming products, production and process controls, acceptance activities, and Quality Audits.
Most common CAPA citations
With CAPA’s being the most common reason, both now and historically, for citations, Drues broke down the most common reasons for complaint-related FDA-483 observations more specifically.
The top issue for manufacturers is not documenting their procedures, followed by not maintaining their complaint files and not investigating known device failures.
Other common problems included complaints not being reviewed and evaluated to determine if further investigation was necessary, not promptly investigating complaints, and complaint records not containing required information.
Most common design control citations
Design Control citations account for over 10% of citations, and Drues broke down the most common design control issues that lead to FDA-483 observations.
The most common issue for companies was not performing a risk analysis, while not documenting the results of a risk analysis came in second.
Other most common issues were a lack of procedures, not validating software, not using production equivalent devices in validation studies, not establishing acceptance criteria prior to validation, not documenting results, and not confirming the device condors to defined user needs and intended uses.
Solving the issue
Drues stressed to the audience that the only way to fix this issue is to take a more active role in your process. Instead of simply ticking boxes, he said manufacturers need to actively be testing things over and over again.
Currently, only 3 – 5% of adverse events are reported to FDA or the manufacturer, Drues said. “In the US, passive post-market surveillance does not work anymore. You have to do active surveillance, find the problems by going out to look for them,” he said. “I cannot emphasize enough, you have to actually go out and look for problems.”
He recommends including criteria in your QMS to answer for any potential issues, and then going through the testing process again and again. “Are we going to be saying the same thing in the next 5 or 10 years? Maybe what we need is a derailment,” he said. “Maybe we should think about the way we’re doing things. Maybe there is a new, different, better way.”
REFERENCE: MD+DI (Medical Device and Diagnostic Industry); 05 FEB 2026; Claire Wallace