1The three classifications.
After an inspection, FDA evaluates the findings to decide whether the facility complies with the applicable laws and regulations, and classifies the inspection.¹ For drug manufacturing, CDER describes the result as an acceptable or unacceptable state of compliance with CGMP.²
| Classification | FDA’s definition | What it means for a drug CGMP facility |
|---|---|---|
| NAI, no action indicated | No objectionable conditions or practices were found during the inspection.¹ | An acceptable state of compliance. Usually no Form 483 was issued.² |
| VAI, voluntary action indicated | Objectionable conditions or practices were found, but FDA is not prepared to take or recommend any administrative or regulatory action.¹ | A “minimally acceptable state of compliance”. Usually a 483 was issued, and FDA recommends addressing its observations.³² |
| OAI, official action indicated | Regulatory and/or administrative actions are recommended.¹ | An “unacceptable state of compliance”. The facility may be subject to regulatory or enforcement action, and FDA may withhold approval of pending applications or supplements that list it.⁴ |
An inspection can be classified OAI whether or not a 483 was issued.⁵ A VAI is not a clean result either: FDA’s VAI letter warns that, if the observations are not corrected, “the same or similar conditions could lead to a future inspection being classified as ‘official action indicated’”.³
2How FDA reaches a classification.
The classification draws on what was collected during the inspection and on what the facility provides afterwards. The investigator’s recommended classification is “an important factor”, and FDA also weighs the facility’s response to the Form 483 and its proposed or completed corrective actions.¹ For drugs, CDER’s compliance review takes in the 483, the Establishment Inspection Report, the evidence collected and the company’s response, and considers the regulations, technical standards, scientific consultation, the facility’s profile and the risk of harm to patients or consumers.² Depending on that review, FDA may concur with, downgrade or upgrade the final CGMP classification.⁵ This is why a well-supported response to the 483 matters.
One inspection can cover several project areas, and each is classified. The Data Dashboard therefore lists a classification for each project area, and can show more classifications than inspections.⁶
3When you hear, and what the letter says.
FDA strives to complete the CGMP classification of human drug facility inspections within 90 days of the end of the inspection. It sends the facility a letter with the classification and generally posts it to the Data Dashboard.² FDA has informed firms of their CGMP status within 90 days since 1 October 2018 as part of its GDUFA commitments, and its target for any regulatory action is within six months of the inspection.⁵
FDA publishes its template letters. The NAI and VAI letters say the classification “will not directly negatively impact” FDA’s assessment of pending marketing applications that reference the facility, although approval still depends on a product- and application-
4What follows an OAI classification.
For a facility with an OAI CGMP inspection, FDA may withhold approval of pending drug applications that list the facility, and export certificates and CGMP declarations for drugs distributed outside the US. Government purchasing contracts may also be affected.² FDA’s tools include warning letters, untitled letters, regulatory meetings, recalls and import alerts such as 66-40. If a facility fails to address CGMP violations, the Department of Justice can bring further action in federal court on FDA’s behalf: injunctions, including consent decrees, seizures and criminal prosecution.² Most of these tools are used mainly after OAI inspections, though some can follow NAI or VAI outcomes.⁵
An OAI does not lift on paper. “Generally, FDA will only change an OAI inspection classification after a company implements comprehensive corrective and preventive actions that are verified through an onsite follow-up FDA inspection.”²
5Where to find a classification.
Once an inspection has been classified and closed, its final classification is added to FDA’s Data Dashboard, which is updated weekly.¹ Some inspections are never listed: those conducted by states, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action, and inspections of nonclinical laboratories, which FDA lists separately.¹ The dashboard also notes that FDA does not issue CGMP certificates at the end of an inspection; it shows the outcome of a firm’s most recent inspection instead.⁶ For the other public records, see how to look up 483s, warning letters and inspection results.
6How it runs in Seal.
In Seal’s inspection readiness workflow, an inspection keeps its authority, scope, sites, products, observations and commitments. Each observation, such as a Form 483 item, is logged with the cited requirement and your response commitments. Follow-up actions link to CAPA and verification evidence links back to the original observation, so an action is not treated as closed because a response letter was sent.
In the QMS, the finding, its evidence and the response sit on the same record as the work. A corrective action can be released as a change to the workflow itself, carrying its procedure version, affected roles, operating controls, verification and approval.
References
- 1Inspection classifications, FDA, April 2024. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ inspection- basics/ inspection- classifications (read 6 November 2026) - 2Pharmaceutical Inspections and Compliance, FDA Center for Drug Evaluation and Research, December 2024. https:/
/ www. fda. gov/ drugs/ guidance- compliance- regulatory- information/ pharmaceutical- inspections- and- compliance (read 6 November 2026) - 3Voluntary action indicated (VAI) classification letter, template, FDA Center for Drug Evaluation and Research. https:/
/ www. fda. gov/ media/ 113124/ download (read 6 November 2026) - 4OAI 90 Day Decisional Letter, template, FDA Center for Drug Evaluation and Research. https:/
/ www. fda. gov/ media/ 113121/ download (read 6 November 2026) - 5Overview of Drug Manufacturing Inspections, Understanding FDA Inspections and Data webinar, FDA, 6 September 2023. https:/
/ www. fda. gov/ media/ 172786/ download (read 6 November 2026) - 6FDA Data Dashboard, Inspections, FDA. https:/
/ datadashboard. fda. gov/ oii/ cd/ inspections. htm (read 6 November 2026) - 7NAI 90 Day Decisional Letter, template, FDA Center for Drug Evaluation and Research. https:/
/ www. fda. gov/ media/ 113096/ download (read 6 November 2026)
AQuestions and answers
Does a VAI classification mean the inspection failed?
No. FDA treats NAI and VAI as acceptable states of compliance with CGMP, and its VAI letter calls the facility minimally acceptable. The letter still recommends fixing the 483 observations, because the same conditions found again could lead to an OAI.
Can an inspection be classified OAI without a Form 483?
Yes. FDA has said an inspection can be OAI whether or not a 483 was issued. FDA’s review of all the inspection evidence decides the classification.
How long does FDA take to classify a drug inspection?
For human drug facilities, FDA aims to finish the CGMP classification within 90 days of the end of the inspection and then sends the facility a letter. Classifications typically reach the Data Dashboard within about a week of the inspection being finalised.
Is an NAI classification a GMP certificate?
No. FDA’s letter says the classification is not an endorsement or certification of the facility, and FDA does not issue CGMP certificates after inspections. On request it issues CGMP declarations for drugs exported from the US, to tell foreign regulators a facility’s status.
How does a facility get out of OAI status?
Generally only by putting comprehensive corrective and preventive actions in place and having FDA verify them at an onsite follow-up inspection. Promises or a response letter alone do not change the classification.
Why can’t I find a pre-approval inspection on the Data Dashboard?
Pre-approval inspections are not included. Nor are state inspections, mammography facility inspections, inspections still waiting for a final enforcement action and inspections of nonclinical laboratories, which FDA lists separately.