Updated October 2024

Benjamin Franklin said, “By failing to prepare, you are preparing to fail.”

This wisdom holds especially true for life sciences companies facing FDA inspections. An essential tool to help companies prepare for and respond to the outcomes of inspections is the Establishment Inspection Report (EIR).

Overview

An EIR is a detailed report written by FDA investigators after they visit and inspect a company’s facility. It summarizes what they found, including the company’s compliance with regulations, any issues identified, and what was discussed during their visit.

An EIR is typically available to the inspected establishment within 30 working days after the inspection is closed, though this often takes longer depending on the district or the specific inspection. Firms should request their EIR from the district office or the office that conducted the inspection. Unlike the Form 483 issued by the investigators at the close of the inspection, the EIR is reviewed and approved by supervisory staff because it includes the assignment of inspection outcome and must be requested after the close of the inspection.

EIRs are categorized into three actions/inspection outcomes:

No Action Indicated (NAI)
Voluntary Action Indicated (VAI)
Official Action Indicated (OAI)

Some features identified in the EIR are:

A physical description of the site(s) inspected
Business history and previous FDA inspection history
Confirmation that the firm engages in interstate commerce, thereby establishing FDA’s authority over the firm
Discussion of the areas and documents evaluated often including conclusions
A list of individuals and their titles with whom the investigators spoke
The Form 483 identifying the exhibits (documents generally) which support the observation
Additional information, including the firm’s response, if any, made at the closing meeting.

For pharmaceutical companies, obtaining their own EIR or those of competitors can be highly beneficial. It can help companies understand how well they are following FDA guidelines and what they need to improve.

5 features to look for in an EIR

These five features provide critical insights into the inspection process, help identify compliance gaps, and offer a roadmap for corrective actions to improve future compliance with FDA regulations.

1. Inspection Scope and Context

The EIR provides more context about the conduct of the inspection than the Form 483 alone. It details the areas and processes the FDA focused on during the inspection. You can often determine how and why the investigators reached specific conclusions and understand the full scope of documents and practices they evaluated. This insight into the investigator’s inspection process can inform inspection readiness activities at your firm. For example, your FDA readiness team could evaluate whether any of the documents are those that have not routinely been requested during inspections and prepare those documents accordingly.

2. Documents Reviewed or Collected

The EIR lists the documents the investigators collected and reviewed for further examination. Knowing which documents were inspected allows companies to ensure their records are complete and compliant with regulations and whether any of the documents reviewed differ from the type evaluated in the past, helping your team prepare the necessary documents.

3. Potential Objectionable Conditions

The EIR will note any problematic practices or potential regulatory violations that need to be corrected prior to the next inspection to avoid further penalties or citations. If the processes or procedures are not corrected by the next inspection, expect them to be cited on the next Form-483. Addressing deficiencies or areas for improvement highlighted in an EIR can help a company avoid the risk of significant regulatory actions.

4. Samples Collected

If the FDA collects samples during the inspection (e.g., product samples, raw materials), the EIR will explain why these were taken. This is important for assessing whether there are concerns related to product quality or safety. If the list is extensive, it can suggest a potential problem. Correct similar issues in your firm accordingly.

5. Enforcement Actions

The EIR will usually indicate if any further actions, such as warning letters, import alerts, or re-inspections, are recommended by the FDA. This gives the company a sense of how severe the issues are and what they need to address to avoid escalating consequences. Address similar or potential problems in your firm accordingly.

Conclusion

In short, an EIR offers pharmaceutical companies vital insights to improve compliance, enhance operations, and mitigate regulatory risks.

By reviewing an EIR, companies can better prepare for future inspections by addressing potential gaps in compliance, ensuring that their facilities meet FDA standards. It is particularly useful for firms to understand what areas the FDA focuses on and how the FDA reviews documents.

The practices and procedures that FDA determined did not meet the seriousness to be cited on the Form 483, but were nevertheless mentioned at the inspection closeout, provide a strong suggestion that FDA expects those to be remediated by the time of the next inspection. A clean or improved inspection report can boost a company’s reputation, showing customers, stakeholders, and investors that it operates in a safe, compliant, and reliable manner.

Did you know that the Redica Systems Document Store is perhaps the only place to reliably find EIRs other than the FDA itself?