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FDA inspection glossary

Establishment Inspection Report (EIR)

An Establishment Inspection Report is the FDA investigator's narrative report of an inspection. It's longer and more detailed than the Form 483.

  • Copy to the firm. Since 1997, FDA has routinely given the inspected firm a copy of the EIR's narrative once the inspection is closed [2].
  • Delayed when action is pending. Inspections that lead to agency action, such as a warning letter, aren't eligible for that release until closed [1].

On FDA Intel

EIRs →

Related terms

Form 483483 responseNAI/VAI/OAI

Sources

  1. FDA guidance document
  2. govinfo.gov/content/pkg/FR-1997-04-14/html/97-9529.htm

See the term in real FDA documents. Your first Form 483 or letter is on us.

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