GeneralLast reviewed April 2026

Establishment Inspection Report(EIR)

The formal written report FDA issues at the conclusion of a facility inspection documenting findings and classification.

Usage Examples

The EIR classified the PAI as NAI, clearing the approval pathway.
An OAI classification in the EIR required Warning Letter response and facility remediation.

What is EIR?

The Establishment Inspection Report (EIR) is FDA's internal official record of an inspection, issued after inspection close. Unlike Form 483 (issued at inspection close with observations), the EIR is a comprehensive narrative report classifying the inspection (NAI, VAI, or OAI), summarizing observations and the firm's response, and recommending follow-up actions.

Firms typically receive a copy of the EIR 30-60 days after inspection close. Redacted EIRs can be obtained via FOIA requests. The EIR classification drives downstream FDA actions: NAI means no further action; VAI means voluntary corrections expected; OAI typically triggers regulatory action (Warning Letter, injunction, consent decree). PAI EIRs with OAI classification generally block the associated application approval until reclassified.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside FDCA, CPG 7356 002.

FDAICHHealth Canada

When This Matters

The EIR classified the PAI as NAI, clearing the approval pathway.
An OAI classification in the EIR required Warning Letter response and facility remediation.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

FDCACPG 7356 002

Frequently Asked Questions

No. Form 483 is issued at inspection close listing observations. The EIR is issued 30-60 days later as the formal internal report with classification, narrative, and recommendations. Both documents are part of the inspection record.

Yes, firms receive a copy as part of post-inspection correspondence. Redacted EIRs for other firms' inspections can be obtained through FOIA. Confidential and trade-secret information is redacted.

Until the next inspection reclassifies. VAI and OAI classifications affect risk-based inspection scheduling, export certification, and PAI outcomes for other applications. Remediation and successful re-inspection are typically needed to restore NAI status.