Inspection Classification Database
Important Notes:
- This database does not represent a comprehensive listing of all conducted inspections and should not be used as a source to compile official data.
- Inspections conducted by States, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action, and inspections of nonclinical labs are not included.
- Inspection data sets of nonclinical labs are available at Nonclinical Laboratories Inspected under Good Laboratory Practices.
- The results show final classifications of No Action Indicated (NAI), Voluntary Action Indicated (VAI), Official Action Indicated (OAI) for each project area within an inspection.
- The Inspections Data Dashboard utilizes its content from FDA compliance and enforcement data that is cleared for public access.
The Food and Drug Administration (FDA) inspects and assesses regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act (FD&C Act) and related Acts. The agency updates an Inspections Data Dashboard weekly that includes final inspection classifications.
FDA discloses a segment of inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of a firm’s inspection information encourages firm compliance and provides the public with an understanding of the Agency’s enforcement actions and an ability to make more informed marketplace choices.
Some inspection data may not be posted until a final enforcement action is taken. Descriptions of posted inspection citations may not necessarily represent citations on the final classification letters.
Inspection Observations
FDA investigators may observe conditions they deem to be objectionable during inspections. These observed conditions or practices are listed on the Form FDA-483 Inspection Observations, Form FDA-4056 Produce Farm Inspection Observations, or notated in the Establishment Inspection Report and indicate that an FDA-regulated product may violate applicable laws and regulations.
Inspected firms are encouraged to respond in writing, within 15 days from the issuance of the FDA- 483, FDA-4056, or verbal observations, by submitting their corrective action plan with supporting documentation, and promptly implement corrective actions to address the cited objectionable conditions. The FDA considers all evidence, including collected documentation and firm responses when determining whether to take regulatory action against a firm.
The agency assigns inspected firms a final classification that includes:
- 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.
FDA’s final inspection classification is usually sent in a letter to the firm within 45 - 90 days from the close of an inspection, depending on the inspection type.
Download this infographic to learn more about the FDA Inspectional Process.
Inspection Classification Importance for Consumers
Sharing the FDA’s inspection information helps the public understand the agency’s inspection process and efforts to protect the public health. This information helps the public make more informed marketplace choices.
Inspection Classifications Importance for Firms
Inspection information encourages firm compliance with applicable laws and regulations to produce and distribute safe products across the United States. The FDA Investigations Operations Manual (IOM) is available publicly so that regulated industry and other external stakeholders can better understand FDA operations. IOM Chapter 5 describes inspectional activities including:
- Inspection Walk-Through
- Procedures and Techniques
- Reportable Observations
- Post-Inspectional Contacts
Whether action is indicated or not after an inspection, the FDA provides the latest information for firms to maintain good manufacturing practices. Regulated small businesses can contact the FDA for assistance.
Resources By Commodity
Check out the Inspections Data Database to review a firm’s compliance status.
Inspection Classification Database and Search
Please use the FDA Data Dashboard for Inspection Classification data.
To learn more about the Inspection Classification Database, please visit the FAQs page.
Questions regarding the Inspection Classification Database may be directed by email to FDAInspectionsClassifications@fda.hhs.gov.