Usage Examples
- The EIR came back NAI, so the site is clear for the application in review.
- Pull the FOIA'd EIR for that CMO before we sign the tech transfer.
- Our 483 response went in three weeks ago; we are still waiting on the EIR to see how FDA classified the inspection.
What is EIR (Establishment Inspection Report)?
An EIR is FDA's full narrative record of a completed facility inspection, prepared after the investigator leaves and assigning the inspection a classification that determines FDA's next action. The Form 483 lists observations; the EIR evaluates them.
An EIR exists because the document a firm receives at the end of an inspection is not an assessment. The Form 483 the investigator hands over before leaving the premises records conditions observed, in his judgment, that indicate insanitary or contaminated product. The EIR is where FDA writes down what the inspection actually established and what the agency intends to do about it.
An EIR covers the whole inspection: what was examined, what the investigator found, how the firm responded, and the classification assigned to the inspection. An EIR is not an enforcement action and not a legal finding. A Warning Letter, an injunction, or a refusal to approve an application is a separate decision FDA makes after reading it.
An EIR is used in practice as the record that carries an inspection's consequences forward. The classification (NAI, VAI, or OAI) travels with the site into approval decisions, risk-based scheduling, and partner due diligence. Copies obtained under FOIA arrive redacted, because trade secret and confidential commercial information are not available for public disclosure, so a public EIR is never the full file.
Not to be confused with
- Form 483
- the Form 483 is handed to the owner, operator, or agent in charge before the investigator leaves the premises and lists only observed objectionable conditions. The EIR is written after the inspection closes and evaluates those observations rather than merely listing them.
- Warning Letter
- a Warning Letter is an enforcement communication FDA may issue after an inspection is classified. The EIR is the underlying record that supports the decision, not the enforcement action itself.
- PAI
- a PAI is a type of inspection, tied to a specific pending application. An EIR is the report an inspection produces, and a PAI produces one just as a routine surveillance inspection does.
- CGMP
- CGMP is the standard the facility is measured against. The EIR is the document recording how the facility measured up against it on a given date.
An EIR is FDA's record, not the firm's, but the inspection it documents creates obligations the firm owns.
What you must do
- 1Respond in writing to the Form 483 observations the investigator gives the owner, operator, or agent in charge before leaving the premises, because the EIR narrative is written after that response and takes it into account21 U.S.C. 374(b)(1)
- 2Correct the manufacturing deficiencies the EIR describes, because a drug whose methods, facilities, or controls do not conform to current good manufacturing practice is adulterated by statute21 U.S.C. 351(a)(2)(B)
- 3Reconcile the EIR outcome against every application in review, because FDA must refuse approval where the methods, facilities, and controls for manufacture, processing, and packing are inadequate to preserve identity, strength, quality, and purity21 U.S.C. 355(d)(3)
- 4Identify what in your inspection record is trade secret or confidential commercial information before an EIR is released, because that material is not available for public disclosure21 CFR 20.61(c)
- 5Treat a released EIR as incomplete while enforcement is open, because law enforcement material may be withheld where disclosure could reasonably be expected to interfere with enforcement proceedings21 CFR 20.64(a)
Common mistakes
Closing the file when the 483 response goes out
the 483 response is an input to the EIR, not the end of it. FDA writes its assessment after the response arrives, and the classification that results is what reviewers, partners, and auditors see afterwards. Firms that stand down at the response letter find out the outcome much later, and sometimes from a Warning Letter.
Reading a FOIA'd EIR as the complete record
trade secret and confidential commercial information are not available for public disclosure, and law enforcement material may be withheld where release could interfere with enforcement proceedings. Supplier diligence built on a redacted EIR systematically understates what FDA actually found at the site.
Not connecting a site's EIR to the application in review
inspection and application review run on different clocks and different desks, so a CMC team can be answering review questions while its manufacturing site carries an unresolved inspection outcome. FDA must refuse approval where facilities and controls are inadequate, and the sponsor absorbs the full delay.
When This Matters
- The EIR came back NAI, so the site is clear for the application in review.
- Pull the FOIA'd EIR for that CMO before we sign the tech transfer.
- Our 483 response went in three weeks ago; we are still waiting on the EIR to see how FDA classified the inspection.
Frequently Asked Questions
No. The Form 483 is the written report of observed objectionable conditions that the investigator must give to the owner, operator, or agent in charge before leaving the premises. The EIR is prepared after the inspection closes and evaluates those observations together with everything else the inspection covered.
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