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  4. Inspections Database Frequently Asked Questions
  1. Inspection References

Inspections Database Frequently Asked Questions

What is an inspection?

The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act. This typically involves an investigator visiting a firm’s location.

Inspections are an important part of the FDA’s activities. They can be used to verify compliance with the laws administered by the FDA, as a surveillance tool in the wake of outbreaks, and to follow up on specific issues such as a product recall or when other risk factors have been identified. The FDA prioritizes inspections using a risk-based approach.

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What are Project Areas?

A single FDA inspection may include multiple activities. FDA inspections and the Inspection Classification Database group inspection activities into project areas. For example, a single inspection might cover drug quality assurance (project area 56) and over-the-counter drug evaluation (project area 61). General information about each project area is described on the project areas descriptions page.

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Why do I see multiple rows for a firm with the same inspection end date?

Since an inspection may evaluate different project areas, the Inspection Classification Database shows each project area in individual rows. When a single inspection evaluates multiple project areas, the database will contain multiple rows.

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What is a Classification?

After an inspection, FDA determines if the areas evaluated are in compliance with applicable laws and regulations. FDA and the Inspection Classification Database classifies the inspection by each project area with one of three classifications. The three classifications displayed are:

  • No Action Indicated (NAI) classification indicates a facility is in an acceptable state of compliance. The facility, usually, was not issued a Form FDA 483 or FDA-4056 at the conclusion of the inspection.
  • Voluntary Action Indicated (VAI) classification indicates the inspection found objectionable conditions or practices but the agency has determined the facility can voluntarily correct its deficiencies and will not recommend any action. Usually, the facility was issued a Form FDA 483 or FDA-4056 at the conclusion of the inspection.
  • Official Action Indicated (OAI) classification indicates a facility is in an unacceptable state of compliance. The facility may have been issued a Form FDA-483 or FDA-4056 at the conclusion of the inspection.

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What does the Inspection Classification Database show?

The Inspection Classification Database shows inspections conducted by FDA and assessments of regulated facilities (though states conduct inspections on FDA’s behalf, those inspections are not captured in the Database). Most inspections FDA conducts are included with several exceptions (such as inspections of mammography facilities and some preapproval inspections). Nonclinical laboratories inspected to determine compliance with Good Laboratory Practices are also not included because those inspections can be found at the nonclinical lab inspection page.

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What is the Inspection Classification Database useful for?

The Inspections Classification Database is a tool to search for the final inspection classifications of many firms and project areas.

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Can I use it to count all FDA inspections?

No. Since not all inspections are disclosed in the Inspection Classification Database, and only those with final classifications are posted, it can’t be used to count all FDA inspections conducted.

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How frequently is the Inspection Classification Database updated?

The Inspection Classification Database is updated weekly.

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How can I get a list of all inspections or specific non-disclosed inspections?

You can make a Freedom of Information Act request by visiting the Freedom of Information website.

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Who can I contact for questions about the Inspection Classification Database?

Questions regarding the Inspections Database may be directed by email to FDAInspectionsClassifications@fda.hhs.gov.

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