Establishment Inspection Report: What FDA Writes After It Leaves

The EIR is the narrative report an FDA investigator writes after an inspection. It is the internal account of what was inspected, what was found, what was discussed, and what the investigator concluded.

You are given the Form 483 at the close of the inspection. You are not given the EIR then. It is written afterwards, reviewed by the district, and it carries the thing that actually matters: the classification.

The three classifications

NAI, No Action Indicated. No objectionable conditions were found, or those found do not warrant further action.

VAI, Voluntary Action Indicated. Objectionable conditions were found, but not at a level warranting formal regulatory action. FDA expects you to correct them voluntarily. Most inspections that produce a 483 end here.

OAI, Official Action Indicated. Objectionable conditions warranting formal action. This is the classification that precedes a warning letter, an import alert, or a withholding of pending applications.

The classification, not the 483, is the outcome. A long 483 classified VAI is a better result than a short one classified OAI, and you cannot tell which you have from the 483 alone.

Why the response you wrote matters here

Your 483 response is read as part of the classification decision. That is the mechanism by which a good response changes the outcome, and it is the reason for the 15 business day window.

A response that credibly addresses the systemic issue can move an inspection that was heading toward OAI. One that corrects only the specific instances usually does not.

Getting a copy

The EIR is available under FOIA, but not immediately. FDA generally releases it once the inspection is closed, meaning classified and any compliance action resolved. For an OAI inspection that can be a long wait.

It arrives redacted, with trade secret and confidential commercial information removed, along with personal information. Even redacted it is worth reading: it tells you what the investigator actually thought, which the 483 does not.

Competitors' EIRs are obtainable the same way, and are a legitimate source of intelligence about what investigators are focusing on at similar sites.

For a pending application

Where the inspection was a pre-approval inspection, the classification gates the application. An OAI classification on a facility named in a pending NDA, ANDA or BLA generally means the application will not be approved until the issues are resolved, and this is one of the more common causes of a Complete Response Letter that has nothing to do with the clinical data.