- What is an inspection?
- What are Project Areas?
- Why do I see multiple rows for a firm with the same inspection end date?
- What is a Classification?
- What does the Inspection Classification Database show?
- What is the Inspection Classification Database useful for?
- Can I use it to count all FDA inspections?
- How frequently is the Inspection Classification Database updated?
- How can I get a list of all inspections or specific non-disclosed inspections?
- Who can I contact for questions about the Inspection Classification Database?
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.
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.
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.
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) which means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action),
- Voluntary Action Indicated (VAI) which means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action, or
- Official Action Indicated (OAI) which means regulatory and/or administrative actions will be recommended.
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.
The Inspections Classification Database is a tool to search for the final inspection classifications of many firms and project areas.
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.
The Inspection Classification Database is updated monthly.
You can make a Freedom of Information Act request by visiting the Freedom of Information website.
Questions regarding the Inspections Database may be directed by email to FDAInspectionsClassifications@fda.hhs.gov.