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Re: FDA Audit - who is "eligible"?
Chris,
You've just summed up my confusion. I was told that this is a "routine inspection" ... not triggered by a customer audit or any type of device approval.
Now, could it be because we *were* registered, until the FDA changed their rules a couple of years back to eliminate registration for contract manufacturers, and we're simply still on their radar?
Dave
Chris,
You've just summed up my confusion. I was told that this is a "routine inspection" ... not triggered by a customer audit or any type of device approval.
Now, could it be because we *were* registered, until the FDA changed their rules a couple of years back to eliminate registration for contract manufacturers, and we're simply still on their radar?
Dave
I got more logical, practical opportunities for improvement from my last FDA audit than I did from my last 3 customer audits combined! For being the big, bad FDA, I have enjoyed working with most of the investigators who have come in here.