EIR
Establishment Inspection Report
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
An Establishment Inspection Report is the FDA investigator’s formal internal report documenting what was observed during an inspection — the facility’s operations, any objectionable conditions found, and the investigator’s overall classification recommendation. It is the official record behind an inspection’s outcome and is distinct from the Form 483, which lists only the observations shared with the firm.
The EIR is drafted after the inspection closes and goes through FDA’s internal review process before the inspection is formally classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). Unlike the Form 483, which the investigator hands to the firm at the close-out meeting, the EIR is an internal document and is not automatically provided to the establishment.
A firm can request a redacted copy of its own EIR under FOIA once the inspection is closed, and EIRs are commonly requested by firms conducting supplier qualification or due diligence on a contract manufacturer or CDMO, since the EIR gives far more narrative context than the terse observations on a Form 483.
- —FDA investigator’s internal narrative report on an inspection, distinct from the Form 483
- —Drives the inspection classification: NAI, VAI, or OAI
- —Not automatically given to the firm; obtainable via FOIA once closed
- —Frequently requested during supplier qualification and CDMO due diligence
FDA Investigations Operations Manual (IOM); 21 CFR Part 20 (public availability of FDA records via FOIA)
Frequently asked questions
What does EIR stand for?
EIR stands for Establishment Inspection Report.
What is EIR?
An Establishment Inspection Report is the FDA investigator’s formal internal report documenting what was observed during an inspection — the facility’s operations, any objectionable conditions found, and the investigator’s overall classification recommendation. It is the official record behind an inspection’s outcome and is distinct from the Form 483, which lists only the observations shared with the firm.
Which regulations cover EIR?
FDA Investigations Operations Manual (IOM); 21 CFR Part 20 (public availability of FDA records via FOIA)