Form 483, Form 482, Form 484, EIR, OAI, NAI and VAI: Terms Related To FDA Inspection

Form 483, Form 482, Form 484, EIR, OAI, NAI and VAI

Form 483, Form 482, Form 484, EIR, OAI, NAI, and VAI are key terms used to describe the inspection process and its results.

The U.S. Food and Drug Administration (USFDA) conducts inspections to ensure compliance with regulatory standards related to the manufacturing, distribution, and safety of food, drugs, medical devices, and other regulated products. During these inspections, the FDA utilises a series of standardised forms and classifications to document findings, communicate with the inspected facility, and determine the necessary follow-up actions.

Understanding key documents—such as Forms 482, 483, and 484—as well as inspection outcomes like NAI, VAI, and OAI, is essential for regulatory professionals to properly manage inspections, respond to observations, and maintain compliance. This overview provides a concise explanation of each form and classification used throughout the FDA inspection process.

USFDA Inspection Forms & Documents

1. Form FDA 482 – Notice of Inspection

• What it is: Official notice that an FDA inspection is about to begin.
• Issued to: The senior management or representative at the facility.
• Purpose: Informs the establishment that an FDA inspector is authorised to conduct an inspection under the Food, Drug, and Cosmetic Act (FDCA).

2. Form FDA 483 – Inspectional Observations

• What it is: A list of potential violations of FDA regulations observed during an inspection.
• Issued to: Company management at the close of the inspection.
• Purpose: Highlights areas of concern for corrective action, but is not a final agency determination.
• Important Note: A 483 can lead to further regulatory actions if not addressed properly.

3. Form FDA 484 – Receipt for Samples

• What it is: Documentation that the FDA has collected product or environmental samples during the inspection.
• Issued to: The facility from which samples were taken.
• Purpose: Ensures transparency and records the chain of custody for the samples.

4. EIR – Establishment Inspection Report

• What it is: A comprehensive written narrative of the inspection findings.
• Prepared by: The FDA investigator after the inspection.
• Purpose: Summarises observations, discussion with management, supporting documents reviewed, and final classification.
• Availability: Can be requested via FOIA (Freedom of Information Act).

Inspection Outcome Classifications

1. NAI – No Action Indicated

• Definition: No objectionable conditions or practices were found.
• Outcome: No further FDA action is expected.

2. VAI – Voluntary Action Indicated

• Definition: Objectionable conditions were found, but they don’t meet the threshold for regulatory action.
• Outcome: The firm is expected to voluntarily correct issues.

3. OAI – Official Action Indicated

• Definition: Serious regulatory violations found that may warrant FDA enforcement actions.
• Outcome: May result in Warning Letters, Import Alerts, Seizures, Injunctions, etc.

Conclusion

A clear understanding of USFDA inspection forms and outcome classifications is critical for maintaining regulatory compliance and ensuring readiness for inspections. Forms such as FDA 482, 483, and 484 document key stages of the inspection process, while classifications like NAI, VAI, and OAI determine the regulatory impact. Proactively addressing observations and maintaining open communication with the FDA can significantly reduce the risk of enforcement actions and support a culture of continuous improvement within regulated facilities.

Frequently Asked Questions (FAQs)

What is an Establishment Inspection Report (EIR)?

The EIR is a detailed summary of the FDA inspector’s findings, discussions, and evidence collected during the inspection.

What does NAI mean in FDA inspections?

“No Action Indicated” (NAI) means no significant violations were found, and no further action is needed.

What does VAI mean?

“Voluntary Action Indicated” (VAI) means minor issues were found. The firm is expected to voluntarily correct them.

What is OAI and what are its implications?

“Official Action Indicated” (OAI) means serious violations were found. This may lead to regulatory enforcement actions such as warning letters or product seizures.