Sourcebrook / Guides / NAI, VAI and OAI
NAI, VAI and OAI: what FDA's inspection classifications mean
Every FDA inspection of a drug or biologics plant ends in one of three classifications. Here is what each means, and how often FDA gave each in 66,781 inspections since October 2008.
Key numbers
- 66,781FDA drug and biologics inspections, 1 Oct 2008 to 10 Sep 2026
- 4.8%classified OAI (3,209); 35.8% VAI, 59.4% NAI
- 256OAI classifications in fiscal 2025, the most in any year since 2009
- 6.6%of inspections were OAI in fiscal 2021–2025, against 4.3% in 2009–2019
The three classifications
After an FDA inspection of a drug or biologics plant, FDA reviews the investigator's report, and the company's response if there is one, and gives the inspection one of three final classifications.
- NAINo Action Indicated
- FDA found no objectionable conditions or practices, or found some that do not justify further action.
- VAIVoluntary Action Indicated
- FDA found objectionable conditions, but is not prepared to take or recommend administrative or regulatory action. The company is expected to correct them.
- OAIOfficial Action Indicated
- FDA will recommend regulatory or administrative action: for example a warning letter, a regulatory meeting, an import alert for a plant outside the US, a seizure or an injunction. OAI is the most serious outcome.
How the classification relates to a Form 483
The classification comes after the inspection, not at its end. At the close of the inspection the investigator hands the plant's management an FDA Form 483 listing any conditions they judged may violate the Food, Drug and Cosmetic Act. A plant that receives a 483 may still end up VAI if its corrections satisfy FDA; an inspection that ends without a 483 is normally classified NAI.
How often each is given
Of the 66,781 drug and biologics inspections FDA's Data Dashboard lists from 1 Oct 2008 to 10 Sep 2026, 59.4% were classified NAI, 35.8% VAI and 4.8% OAI. Inspections fell during the pandemic, from 4,286 in fiscal 2019 to 1,428 in fiscal 2021, and have since recovered to 3,725 in fiscal 2025. The share classified OAI has stayed higher since: 6.6% in fiscal 2021–2025, against 4.3% in 2009–2019.
| Fiscal year | Inspections | NAI | VAI | OAI | OAI share |
|---|---|---|---|---|---|
| FY2009 | 3,885 | 2,207 | 1,503 | 175 | 4.5% |
| FY2010 | 4,406 | 2,526 | 1,716 | 164 | 3.7% |
| FY2011 | 4,708 | 2,798 | 1,720 | 190 | 4.0% |
| FY2012 | 4,714 | 2,697 | 1,864 | 153 | 3.2% |
| FY2013 | 4,412 | 2,649 | 1,565 | 198 | 4.5% |
| FY2014 | 4,524 | 2,811 | 1,535 | 178 | 3.9% |
| FY2015 | 4,364 | 2,624 | 1,530 | 210 | 4.8% |
| FY2016 | 4,476 | 2,699 | 1,578 | 199 | 4.4% |
| FY2017 | 4,213 | 2,582 | 1,406 | 225 | 5.3% |
| FY2018 | 4,391 | 2,698 | 1,522 | 171 | 3.9% |
| FY2019 | 4,286 | 2,598 | 1,482 | 206 | 4.8% |
| FY2020 | 1,998 | 1,230 | 681 | 87 | 4.4% |
| FY2021 | 1,428 | 804 | 498 | 126 | 8.8% |
| FY2022 | 2,639 | 1,571 | 894 | 174 | 6.6% |
| FY2023 | 3,084 | 1,810 | 1,100 | 174 | 5.6% |
| FY2024 | 3,324 | 1,878 | 1,235 | 211 | 6.3% |
| FY2025 | 3,725 | 2,080 | 1,389 | 256 | 6.9% |
| FY2026 (to 10 Sep 2026) | 2,204 | 1,417 | 675 | 112 | 5.1% |
By country
In this period FDA inspected drug and biologics plants in 103 countries. Plants in the United States account for 78% of inspections, and 4.5% of them were classified OAI; for plants elsewhere the share is 5.9%. Among countries with at least 300 inspections, the highest OAI shares are Korea (12.3%), China (10.9%), India (10.4%).
| Country | Inspections | OAI | OAI share |
|---|---|---|---|
| United States | 51,775 | 2,321 | 4.5% |
| India | 2,955 | 307 | 10.4% |
| China | 1,619 | 177 | 10.9% |
| Germany | 1,131 | 17 | 1.5% |
| Canada | 951 | 58 | 6.1% |
| Italy | 881 | 21 | 2.4% |
| France | 773 | 20 | 2.6% |
| United Kingdom | 691 | 26 | 3.8% |
| Japan | 625 | 20 | 3.2% |
| Spain | 527 | 16 | 3.0% |
| Switzerland | 424 | 6 | 1.4% |
| Korea (the Republic of) | 341 | 42 | 12.3% |
| Poland | 318 | 4 | 1.3% |
| Ireland | 312 | 3 | 1.0% |
What the dashboard does not show
FDA's Data Dashboard lists final classifications only and leaves out pre-approval inspections, and a classification appears only after FDA's review. Companies sometimes disclose the outcome first, in their own SEC filings: Bausch Health's 10-Q of 30 July 2026 reported an OAI at its Tampa, Florida plant from June, while the dashboard in mid-September still listed the plant's 2023 “No Action” inspection as its latest. Of 52 plant problems we matched in company filings since 2009, 22 never appeared on the dashboard. How Sourcebrook adds company disclosures.
How we count
Source: FDA Data Dashboard, inspection classifications for the Drugs and Biologics centers, 1 Oct 2008 to 10 Sep 2026 (the latest inspection end date in the data). The dashboard has one row per inspection, project area and product type; we keep one row per inspection with its most serious classification (OAI over VAI over NAI). Countries are as FDA records each plant's address.