Initial Audit FDA

#1
Looking for some information. We are new company, now have been doing business for 4 years. We still have not been audited from the FDA. We have a class I 510 (k) exempt product on the market. When would we expect an audit likely to occur?
 
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blackholequasar

The Cheerful Diabetic
#2
To be honest, with an exempt product? You're probably further down on the totem pole as far as unannounced visits go. From what I've seen/heard, they're understaffed as it is trying to get audits in for larger corporations. May work in your favor as far as getting audited yourself! I worked in spinal with a 510(k) approved device and for the 4 years I was there, we had no audit. That was 4 years ago and they still have not had an audit. (But they do have a consultant come in biennially for their own benefit)
 
#3
Thank you. This helps. We have been doing just that, having Mock FDA audits every third year in addition to the internal audits that we are doing. Appreciate it.
 

Ronen E

Problem Solver
Moderator
#4
Looking for some information. We are new company, now have been doing business for 4 years. We still have not been audited from the FDA. We have a class I 510 (k) exempt product on the market. When would we expect an audit likely to occur?
I wouldn't be surprised it it took them a decade from the initial establishment registration / first device shipment, to finally show up. I'm also quite sure it will be an announced inspection; unless something really bad happens with your device in the field earlier.
 
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