FDA Inspection Statistics 2026
Comprehensive analysis of FDA facility inspections — OAI, VAI, and NAI classification outcomes, most-inspected companies, geographic distribution, product types, and FDA center activity. Sourced from official FDA databases, updated regularly.
Key Figures
| Metric | Value |
|---|---|
| Total FDA inspections tracked | 273,379 |
| Inspections in FY2026 | 10,473 |
| Most inspected company | delta air lines (1,078) |
| Top state by inspections | California (30,916) |
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Overview
A high-level snapshot of FDA facility inspection activity across all classifications, product types, and FDA centers.
Inspections by Classification (OAI / VAI / NAI)
After an inspection, the FDA assigns a classification outcome. OAI (Official Action Indicated) is the most serious — it means the FDA found significant objectionable conditions and will take regulatory action such as a Warning Letter or consent decree. VAI (Voluntary Action Indicated) means objectionable conditions were found but the firm is expected to correct them voluntarily. NAI (No Action Indicated) means no significant objectionable conditions were found.
| Classification | Description | Inspections |
|---|
Yearly Trends & Classification Breakdown
Annual inspection counts by fiscal year with OAI/VAI/NAI classification stacked breakdown, showing trends in FDA enforcement activity over time.
| Fiscal Year | OAI | VAI | NAI | Total |
|---|
Top Inspected Companies
The 20 most frequently inspected companies by the FDA, based on normalized legal entity names. High inspection counts may reflect large facility footprints, regulatory history, or product scope.
| # | Company | Inspections |
|---|
Geographic Distribution
Top 15 U.S. states by number of FDA inspections. Concentration tends to correlate with states that have large pharmaceutical manufacturing, medical device, and food production sectors.
| # | State | Inspections |
|---|
Product Type Breakdown
FDA inspections span multiple product categories including drugs, biologics, devices, food/cosmetics, veterinary products, and more.
| Product Type | Inspections |
|---|
FDA Center Breakdown
Inspections are conducted by different FDA centers: CDER (drugs), CDRH (devices/radiological health), CBER (biologics), CFSAN (food safety/nutrition), CVM (veterinary medicine), and ORA (regulatory affairs).
| FDA Center | Inspections |
|---|
Frequently Asked Questions
How many FDA inspections are there per year?
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What do OAI, VAI, and NAI mean?
These are the three FDA inspection classification outcomes. OAI (Official Action Indicated) means the FDA found significant violations and will take regulatory action — such as issuing a Warning Letter, import alert, or seeking a consent decree. VAI (Voluntary Action Indicated) means the FDA found objectionable conditions, but expects the company to voluntarily correct them without formal enforcement. NAI (No Action Indicated) means the inspection found no significant objectionable conditions or violations.
Which companies are inspected most by the FDA?
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What triggers an FDA inspection?
FDA inspections can be triggered by several factors: routine surveillance schedules (the FDA inspects domestic drug manufacturers every 2 years on average), pre-approval inspections for new drug or device applications, for-cause inspections prompted by adverse event reports or complaints, follow-up inspections after previous OAI or VAI findings, compliance follow-ups to Warning Letters, and import inspections at ports of entry. The FDA uses a risk-based approach to prioritize which facilities to inspect.
Explore FDA Inspection Data Further
- Browse OAI inspections — Official Action Indicated outcomes
- Browse all FDA inspections by date and classification
- Query FDA inspections & Form 483 citations via API
- Related dashboards: warning letter & compliance statistics, FDA recall statistics
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Get API Key — Free/api/stats/inspections endpoint.Disclaimer: This analysis is provided for informational purposes only and should not be used as the sole basis for regulatory decisions.