FDA Inspections

[dj123]

Hi all. For background: A sister company has a mix of Class 1 and 2 products that are all 510(k) exempt, but not all are GMP exempt.

Having only worked at Class III places before, I can't say I have any knowledge of FDA inspection requirements for these kind of devices, nor can I find a definitive document to state if it is risk-based (so they might) or risk-based (so they won't) inspect. Or is as simple as no inspections if you're not involved in premarket approval?

Thanks in advance

 

[yodon]

I think I heard once that FDA is supposed to inspect every registered establishment with product on the market every few years. Not sure if that's true, but I don't think they have enough inspectors to do that so they prioritize (and outsource some; e.g., I've had 2 clients here in TX that were inspected by TX Health for FDA). Certainly, if there are adverse events reported with your product, you're going to be on the radar (priority increased).

I wouldn't suggest that you can assume you won't be inspected. Be prepared.