3 Surefire Ways to Fail FDA Inspection

As a medical device company, you do know that a FDA Inspection will happen, right? FDA is supposed to inspect all medical device companies with class II (and higher) devices at least every two years. You should be prepared for that FDA inspection.

Good news. FDA tells you how they will inspect you in the “Guide to Quality System Inspections”, more collectively known as QSIT.

qsit, FDA inspection

Have you ever wondered what are the top issues cited by during a FDA inspection? These “issues” are known as 483 inspectional observations, mostly because FDA documents the issues on form 483.

And you can visit the FDA website to view FDA 483 inspectional observation data for FY2013.

Over 4000 observations were to medical device companies during FDA inspection activities in 2013.

Our friends at Medical Device Academy have analyzed FDA 483s from 2013.

Top 3 483 Observations During FDA Inspections of Medical Device Companies

  1. Design Controls – 13.25% of all 483s issued in FY2013
  2. Corrective Action & Preventive Action (CAPA) – 11.75% of all 483s issued in FY2013
  3. Complaint Handling – 10.65% of all 483s issued in FY2013

Add the numbers up. 35% of 483 observations during a FDA inspection pertain to Design Controls, CAPA, and Complaints.

Oh, but your Design Controls, CAPA, and Complaints are just fine. Right?

Okay. Wanna guarantee your medical device company gets 483 observations during your FDA inspection? Here are 3 surefire ways to make this happen.

1. Ignore Documenting Design Controls

What’s the big fuss about Design Controls? Your team does a good job and tests all the products being developed. Plus, you submitted a 51o(k) and received clearance. Surely, this is sufficient? That 510(k) submission had so many pages of a paper that a redwood forest died so you can get your product to market.

Why worry about User Needs, Design Inputs, Design Outputs, Design Verification, Design Validation, and the other Design Control stuff. The project is moving to production soon, and everyone is ready to go to market.

Okay, maybe you should have done a better job capturing Design Controls throughout the project. But it’s too late now. You’ll do a better job on the next project.

2. Who needs CAPAs?

When you learn about a product issue, you jump in and fix it. Why bother with going through corrective and preventive actions (“CAPA”)?

Besides, the existing CAPA process is confusing and difficult to follow. CAPAs are only necessary for the really big issues. Not the stuff you are dealing with.

You are the type of person who just wants to get things done. Yes, you accept that from time to time you are going to have to address and fix issues. And you do a good job of identifying what needs to be fixed and do a thorough job of testing before implementing any changes. CAPA will only slow you down.

3. Why capture Complaints?

How many times have you heard about someone using your product incorrectly? Why in the world is this your issue? Why would you have to document and investigate misuse of your medical device? The last thing you think is necessary is to document this as a complaint.

And what about all the other times when you hear about something breaking or not working as you intended with your medical device? Why not just fix the issue? Complaint investigations are not really needed. Again, you just want to get things done.

Complaints are a bad word. Having complaints is like admitting faults. Sure, there are ways you can improve your products. But you shouldn’t have to identify issues and document them as formal complaints.


Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handles Design Controls. Because of this greenlight.guru was born. You can find him on Google+,Twitter, and LinkedIn

Related Posts

No Comments Yet.

add new comment