How often does the FDA inspect organisations outside of the USA?

[brandomenon]

My previous company, located in Ontario, had mutliple locations in the US that were inspected every other year (or every year when 483's were found). The non-US facility where I worked was only inspected every 5 years or so (1996, 2001, 2006)

 

[Weiner Dog]

I believe that FDA is planning on opening inspectional offices in Europe and Asia. (Something that I wish would have happened when I was still with the FDA...) As such, foreign inspectional visits should occur more often. However, I do not think that they will be visiting foreign sites with the same frequency as US sites... however, the pendulum is turning the other way now with a democratic president...

 

[Trackerii]

My old company, class I and II devices, was not audited for 20 years. Then within a period of 2 years we were audited twice in the US, twice in Canada and one 2 weeks audit in Germany and Brussels. I think that was a result of a class III submission.

At another company we did get audited regulary, every 2 years, in Mexico.