FDA's Inspection Frequency for Foreign Manufacturer

[yzl1018]

Dear all,

Our factory is a foreign medical manufacturer. However, I am wondering about the FDA's inspection frequency for foreign manufacturer. Could you please kindly show me any US regulation or guidance on this aspect?
In addition, could you please also show me the regulations about the determination criteria of 483 and warning letter?

Thank you in advance!

 

[GenDir]

Hi,

Some information directly from the FDA homepage:

http://www.fda.gov/downloads/AboutF...ndTobacco/CDRH/CDRHTransparency/UCM416501.pdf