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FDA Establishment Inspection Reports (EIRs)

The investigator’s full narrative of an inspection: what they reviewed, who they spoke to, what they found and what management said.
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$550

per EIR, no subscription. Your first Form 483 or letter is on us.

What an EIR is, and why it matters

An Establishment Inspection Report is written by the FDA investigator after an inspection. Where a Form 483 lists observations in a few pages, the EIR tells the whole story: the scope of the inspection, the firm’s history, the products and processes covered, the records reviewed, each objectionable condition and the discussion with management.

FDA classifies every inspection as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI), and the EIR is the record that supports that classification. It also documents inspections that ended with no 483 at all.

Because it shows how an investigator worked through a site, which documents they asked for and how they followed a thread, the EIR is the most useful document for preparing a team for an inspection or judging a supplier’s inspection history.

What’s inside an EIR

The parts you will find in almost every one, and what each tells you.

  1. Summary

    Why FDA inspected, what was covered and how the inspection ended.

  2. Administrative data

    Firm, FEI, inspection dates, investigators and the people FDA met.

  3. History and operations

    The firm’s inspection history, products, processes and responsibilities.

  4. Objectionable conditions

    Each finding in detail, with the evidence and management’s reply.

  5. Discussion and exhibits

    The close-out discussion, samples taken and the exhibits attached.

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Questions

What is an FDA Establishment Inspection Report?

An EIR is the FDA investigator’s narrative report of an inspection. It covers the scope, the firm’s history and operations, each objectionable condition with evidence, and the discussion with management.

How is an EIR different from a Form 483?

A 483 is a short list of observations handed to the firm at the end of the inspection. The EIR is written afterwards and is much longer, explaining what the investigator reviewed and why each observation was made.

When does a firm receive its EIR?

FDA generally sends the firm a copy of the EIR after the inspection is classified and closed.

Is there an EIR when no 483 was issued?

Yes. Inspections that end without a 483 still produce an EIR, which records what was covered and why nothing was cited.

How much does an EIR cost on FDA Intel?

$550 per EIR, paid by card with no subscription. Your first Form 483 or letter is on us.

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$550 per EIR. Your first Form 483 or letter is on us.

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