FDA EIR Writing Practice Test: 15 Inspection Questions

The Establishment Inspection Report (EIR) is the FDA investigator’s official record of an inspection: a comprehensive internal narrative that documents everything observed, reviewed, and discussed during a facility visit, and recommends how the inspection should be classified. Unlike Form 483, which lists objectionable conditions in a standardised format, the EIR tells the full story behind those conditions.

This practice test covers EIR structure and content, the relationship between the EIR and Form 483, classification recommendation standards, investigator conduct requirements, disclosure obligations under Field Management Directive 145 and FOIA, and how the EIR’s narrative affects subsequent enforcement decisions. Questions are drawn from FDA’s Investigations Operations Manual (IOM), Field Management Directive 145, CBER SOPP 8504, 21 CFR Part 20, and regulatory practice literature.

Key principle before you start: The EIR is a releasable document under FOIA. FDA’s Investigations Operations Manual explicitly instructs investigators to refrain from making judgments as to the acceptability or non-acceptability of the firm in the EIR because of this releasability. The investigator makes a classification recommendation; the Center makes the final determination.

Section 1: EIR Fundamentals

Question 1 | Beginner

What is the primary purpose of the Establishment Inspection Report (EIR)?

A) To notify the inspected firm of the final inspection classification before it is publicly released
B) To serve as the FDA investigator’s official internal record of the inspection, documenting findings, observations, firm responses, and the recommended classification
C) To replace Form 483 when no objectionable conditions were found
D) To document only the conditions that were not included on Form 483

Question 2 | Beginner

An FDA investigator completes an inspection during which no objectionable conditions were found and no Form 483 was issued. Is an EIR still required?

A) No, the EIR is only required when a Form 483 is issued
B) No, for NAI inspections the inspector files a simplified summary instead
C) Yes, an EIR is prepared after every inspection regardless of outcome
D) Only if the inspection lasted more than one day

Section 2: EIR Content and Structure

Question 3 | Intermediate

Which of the following is NOT a standard component of an FDA EIR?

A) A list of documents reviewed during the inspection
B) The names and titles of personnel interviewed
C) A final determination that the facility is approved or not approved
D) A narrative description of the facility’s quality systems and manufacturing processes

Question 4 | Intermediate

What is the relationship between the Form 483 and the EIR?

A) The Form 483 replaces the EIR when the inspection results in a VAI classification
B) The EIR elaborates on and provides narrative context for the conditions listed on the Form 483, and also documents additional discussion items and investigator analysis not included on the 483
C) The Form 483 and EIR are identical documents with different distribution channels
D) The EIR supersedes the Form 483 and the 483 is discarded after the EIR is finalised

Section 3: Classification Recommendations

Question 5 | Intermediate

An investigator recommends VAI in the EIR after issuing a Form 483 with two observations. The Center reviews the EIR and the firm’s 483 response and determines the response was inadequate. What can the Center do?

A) Accept the VAI recommendation without modification, since the EIR is the investigator’s determination
B) Upgrade the classification to OAI based on the inadequate 483 response, without requiring a follow-up inspection
C) Downgrade the classification to NAI if the firm’s response addressed most of the observations
D) Issue a second Form 483 with additional observations

Question 6 | Beginner

FDA’s Inspections Classification Database shows final classifications of NAI, VAI, and OAI. What does a VAI classification indicate?

A) The facility was not inspected and the classification is based on prior records
B) Objectionable conditions or practices were found, but FDA has determined the facility can voluntarily correct them without mandatory regulatory action
C) FDA plans to issue a warning letter within 30 days
D) The facility must be re-inspected within 90 days

Section 4: EIR Disclosure and FOIA

Question 7 | Intermediate

Under Field Management Directive 145, when is the EIR narrative released to the inspected establishment?

A) Immediately after the closeout meeting, before the final classification is issued
B) Within 5 business days of the inspection ending
C) After the inspection is deemed “closed” under 21 CFR Section 20.64(d)(3), typically 3 to 6 months post-inspection
D) Only upon request through FOIA, with no proactive release obligation

Question 8 | Advanced

A competitor pharmaceutical company requests copies of five EIRs from inspections at another manufacturer via FOIA. Which statement best describes this situation?

A) EIRs cannot be requested through FOIA by third parties
B) EIRs are available through FOIA from other facilities, but portions will be redacted to protect confidential commercial information and personal privacy
C) EIRs from foreign inspections are available through FOIA but domestic EIRs are not
D) The requesting company must demonstrate a direct regulatory interest before FOIA access is granted

Section 5: Investigator Conduct Standards

Question 9 | Intermediate

FDA’s IOM instructs investigators to conduct themselves with “honesty, diplomacy, tact, and persuasiveness.” At the closeout meeting, facility management disagrees with one of the Form 483 observations. What should the investigator do?

A) Remove the disputed observation from the Form 483 to avoid conflict
B) Argue with management to establish the correctness of the observation
C) Note the disagreement without arguing, and report the management’s different view in the EIR
D) Issue a second Form 483 with the disputed observation restated in stronger terms

Question 10 | Beginner

During an inspection, the facility’s quality director tells the investigator verbally that a CAPA for a previously cited deviation was completed two months ago. How should this be handled?

A) The verbal statement is sufficient; the investigator records it in the EIR and no further documentation is needed
B) The investigator should request documentary evidence of the CAPA completion and review it during the inspection
C) Verbal confirmation from a quality director is equivalent to documentation under ALCOA principles
D) The investigator cannot review CAPA records without a prior written request submitted 30 days before the inspection

Section 6: Scenario-Based Questions

Question 11 | Advanced — Scenario

A pharmaceutical manufacturer receives its EIR six months after a VAI inspection. Reading the EIR narrative, the quality director notices that the investigator documented reviewing 15 batch records across three product lines and found no issues with any of them, but also noted spending two full inspection days examining the firm’s environmental monitoring data, ultimately not issuing any 483 observations in that area. What should the quality director conclude from this?

A) Environmental monitoring is clearly not an area of regulatory concern since no observations were issued
B) The investigator’s focus on environmental monitoring for two days, without an observation, suggests this area is under significant scrutiny and should be proactively reviewed and strengthened
C) The batch records are the higher-risk area because the investigator reviewed 15 of them
D) EIR narratives describing areas with no observations have no practical value for the inspected firm

Question 12 | Advanced — Scenario

During an inspection, the FDA investigator asks to photograph a manufacturing process. The facility’s legal counsel, who is present, advises that photographs should not be permitted without more clarity on how they will be used. The investigator proceeds to document the same conditions through written notes instead. How should this situation be handled going forward?

A) Refusing photography is a legal right and the investigator cannot include written descriptions of the same conditions in the EIR
B) The facility should have a documented inspection procedure that addresses photography and recording device policies before an inspection begins, to manage such requests consistently
C) Once the investigator substitutes written notes, the photographed conditions cannot be cited in any 483 observation
D) Refusing photography automatically triggers an OAI classification

Section 7: Advanced Topics

Question 13 | Advanced

What distinguishes a “for-cause” inspection from a “surveillance” (routine) inspection in terms of the EIR?

A) For-cause EIRs are shorter because they focus only on the specific cause that triggered the inspection
B) For-cause EIRs are not subject to FOIA release
C) The EIR format is the same, but for-cause inspections typically result in more focused scrutiny of specific processes or systems, and the EIR’s narrative may document investigative findings not typical of a routine surveillance report
D) For-cause inspections do not produce an EIR unless the classification is OAI

Question 14 | Intermediate

True or False: An investigator writing an EIR should include their personal opinion about whether the firm’s management is committed to quality.

True
False

Question 15 | Advanced

A firm receives a Warning Letter citing failures to address observations from a previous inspection. The Warning Letter references the EIR. What does this indicate about how the EIR was used in the enforcement process?

A) The EIR was used as the sole basis for the Warning Letter, without a review of the 483 response
B) The EIR, alongside the 483 and the firm’s response, was used by the Center in determining that the firm’s corrective actions were inadequate and that official action was warranted
C) The Warning Letter’s citation of the EIR means the EIR is no longer releasable through FOIA
D) The citation of an EIR in a Warning Letter means the inspection was reclassified from VAI to NAI

Quick Reference: Key Concepts Tested

Core principles from this practice set

✓EIR is prepared after every inspection, regardless of classification outcome

✓Investigators do not make final approval/rejection determinations in the EIR

✓The Center, not the investigator, issues the final classification

✓A recommended VAI can become a final OAI based on an inadequate 483 response alone

✓FMD 145 mandates proactive EIR release to the inspected firm after inspection closes

✓EIRs from other facilities are available through FOIA (with redactions)

✓Investigator conduct standards: honest, diplomatic, non-argumentative; all discussions reported in EIR

Knowledge check: A firm’s EIR narrative shows the investigator spent considerable time reviewing data integrity controls but issued no 483 observation in that area. Three months later the firm plans a major expansion of its electronic record-keeping system. Should the EIR finding influence how the firm approaches the new system? Yes. The investigator’s extended focus on data integrity, even without a citation, signals that this area is under active regulatory scrutiny. Any expansion should be designed with full compliance with 21 CFR Part 11, including audit trail architecture, access controls, and system validation documentation. The absence of a 483 observation should be read as “currently acceptable,” not as “not a regulatory priority.”

Supporting Resources

A comprehensive guide to FDA establishment inspections, covering all four phases, the three classification outcomes, and preparation strategies, is available in the Guides section.
An Insights analysis of FDA 483 observation trends in FY2024, including the top citation categories and enforcement pattern shifts, is available in the Insights section.
FDA Investigations Operations Manual Chapter 3: Establishment Inspections
FDA Inspection Classification Database
ORA FOIA Electronic Reading Room (published 483s and EIRs)

FDA EIR Writing: 15 Practice Questions