How to Fail an FDA Medical Device Inspection in 3 Easy Steps!

How to Fail an FDA Medical Device Inspection in 3 Easy Steps!

October 11th, 2018 // 1:30 pm @

Have you ever thought about what the most common issues are in an FDA 483 for medical device manufacturers? The Medical Device Academy recently analyzed FDA 483s from 2013, and the research found that the most common observations were regarding design controls, CAPAs, and complaint handling. Design control problems were in 13.25% of all FDA 483s issued in 2013; CAPA problems were in 11.75%; and complaint handling was in 10.65%. A full 35% of all FDA 483 observations for medical device manufacturers that year were due to these three problems.

So, if you want to fail your FDA inspection, here is more information about these items so you can fail it very easily!

Failing to Document Design Controls

What is the big deal about design controls? Your employees did a great job and have tested all of the products the company is developing. You also submitted a 510(k) and got clearance from FDA. Isn’t that enough? Why should you worry about things such as design inputs, user needs, design outputs, design verification and design validation? The device is going to production and it will be ready to be marketed soon. Actually, capturing design controls etc. is very important if you want to avoid this observation on the 483.


When you learn about a problem with a medical device, you just go and fix it, right? Why hassle with corrective and preventive actions? After all, the CAPA process is confusing and it really is only needed for serious problems, right? Actually, you do need to follow the CAPA process even for the most minor corrective and preventive actions so that there is a written record of what went wrong and how it was fixed.


Customers often use a product incorrectly, and some medical device manufacturers wonder why this is their problem. Why should you need to document and investigate when someone misuses your medical device? Well, FDA requires medical device manufacturers to carefully document all of this. Complaints also need to be carefully documented when something breaks or does not work as intended on the medical device.

If you want to ensure that you get an FDA 483 with plenty of observations, just be sure to ignore the three items above.

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