Has the facility been inspected? question in Certificate to Foreign Government application

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jerryz

jzsn
#1
#1
During the application for a Certificate to Foreign Government with CDRH, there is a step that ask for "Has the facility been inspected by FDA?" and provide date of last inspection. I know this is when the reviewer will go to look if the applicant has any outstanding observations from the last inspection and may be ground for denial of the CFG application. Does this means for new applicant that had not had any FDA inspection in the past, the CFG will be rejected as well? Is Inspection mandatory? ISO 13485 certification won't suffice as there is no place that asks for this cert?
 
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