Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work

JJ_FDA

Involved In Discussions
#1
Is it usual for potential clients to ask for (all / the most recent) FDA EIRs / 483s when evaluating a CRO for future work? Do CROs usually comply with the request?
 
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Stijloor

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#2
A Quick Bump!

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ScottK

Not out of the crisis
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Super Moderator
#3
Speaking as a contract manufacturer - yes, it is common. No, you don't have to share. That's a business decision.
What I usually do when I get a request for that is summarize the finding(s) and say that we do not share inspection reports outside of the company.

If you got a warning letter, that's public knowledge and can be looked up.
 
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