Hello everyone!
I have a couple of questions about how to build the FDA inspection preparedness team.
I am working for a medical device manufacturer outside of the US, which has one facility for design work and several factories which manufacture devices (no design work) outside of the US.
My questions are
1. When FDA inspects our factories, will the FDA investigator question any design-related things such as 510k, device listing, or design validation? Even though the facility does not do any design?
2. Are we allowed to just simply say “We can’t answer because this place does not do any design work”?
3. If there is any chance of being asked about design work at the factories? If yes, would it be better for us to include design members in the FDA inspection preparedness team and ask them to attend the inspection?
4. Could anyone share with me how you have built the team for the FDA inspection at factories?
Thank you very much for your help in advance.
I have a couple of questions about how to build the FDA inspection preparedness team.
I am working for a medical device manufacturer outside of the US, which has one facility for design work and several factories which manufacture devices (no design work) outside of the US.
My questions are
1. When FDA inspects our factories, will the FDA investigator question any design-related things such as 510k, device listing, or design validation? Even though the facility does not do any design?
2. Are we allowed to just simply say “We can’t answer because this place does not do any design work”?
3. If there is any chance of being asked about design work at the factories? If yes, would it be better for us to include design members in the FDA inspection preparedness team and ask them to attend the inspection?
4. Could anyone share with me how you have built the team for the FDA inspection at factories?
Thank you very much for your help in advance.
