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


Involved In Discussions
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?


Super Moderator
A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!


Not out of the crisis
Super Moderator
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.
Top Bottom