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I concur with Peter: the observations of the inspector may be modified or removed by management, which is one reason why it takes so long for the EIR to become available. Additionally, it may be useful to have a third party, such as a regulatory consultant ...

First, the FDA Investigator's observation is not the final agency decision. If you are unable to change the Investigator's mind and the issue finally appears on an FDA-483, you can respond (within 15 business days) and explain your point. Don't argue ...

This message was posted by a user wishing to remain anonymous How do you handle it when, even after your pushback, an FDA investigator still insists on reporting your firm as having violated FDA law or regulations, when in fact your firm hasn't?  Specifically, ...

Hi everyone, As a new member of RAPS, I wanted to express how much I am enjoying my experience so far. I have encountered a question for which I have been unable to find an answer. Recently, my boss left the company after establishing a communication ...

The term "root cause analysis" is used to describe an investigation that uses the 5 Questions approach to discover the actual source of a deviation, nonconformity, whatever you choose to call it, as there is usually a sequence of events involved. If one ...