FDA Inspections

Data through 29 October 2026.

Drug, device and biologics inspections

123,700

Newest inspection ended

29 October 2026

Drugs inspections

40,549

Devices inspections

50,687

Biologics inspections

32,464

Classifications

NAI: No Action Indicated

73,936

VAI: Voluntary Action Indicated

43,358

OAI: Official Action Indicated

6,406

Inspections by fiscal year and classification

FY 2027 (to 29 October 2026)0% of classified inspections were OAI

96 NAI · 19 VAI · 0 OAI

FY 20264% of classified inspections were OAI

2,987 NAI · 1,558 VAI · 206 OAI

FY 20256% of classified inspections were OAI

3,662 NAI · 2,317 VAI · 389 OAI

FY 20246% of classified inspections were OAI

3,351 NAI · 2,090 VAI · 321 OAI

FY 20235% of classified inspections were OAI

4,106 NAI · 2,064 VAI · 310 OAI

FY 20224% of classified inspections were OAI

3,906 NAI · 1,643 VAI · 235 OAI

Counts are inspections with a final classification in drugs, devices and biologics.

Source: FDA's Data Dashboard inspections classifications dataset, read at build time and refreshed at most daily. FDA says the dataset is not a complete list of inspections. Fiscal years run from 1 October.

Fiscal years 2023 to 2025. Data through 20 October 2026.

FDA posted citations for 1,479 drug inspections and 1,933 device inspections that ended in these three fiscal years. The tables rank the CFR references by how many of those inspections cite them. The full analysis covers trends since 2009, sites outside the United States, and which citations go with OAI outcomes.

Device citations since the QMSR took effect on 2 February 2026

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented

124 inspections

ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

96 inspections

ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented

91 inspections

ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established

74 inspections

ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated

59 inspections

ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented

49 inspections

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes

44 inspections

ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented

38 inspections

375 of 404 device inspections that ended from 2 February 2026 to 20 October 2026 cite a clause of ISO 13485:2016. 19 cite a section of 21 CFR Part 820. Recent months are still filling in.

Source: FDA Data Dashboard inspection citations for drugs, devices and biologics, counted by scripts/build-inspection-citations.py in the repository that builds this site. Share is the fraction of inspections with posted citations that cite the reference.

Pick a product type, a span of fiscal years and where the site is. The table ranks the CFR references cited on posted Form 483s. Open one for its trend, its OAI rate and recent firms cited.

Loading the citation data (about 50 KB).

The FDA inspection database is FDA's Inspection Classification Database. It lists inspections of regulated facilities with the final classification FDA gave each one: No Action Indicated, Voluntary Action Indicated or Official Action Indicated. FDA publishes it through its Data Dashboard, and says it updates the dashboard weekly.

This tool searches that data for drug, device and biologics sites. Food and tobacco inspections make up most of the full dataset and are left out. Pick a product type to narrow further.

It also reads a second FDA dataset, the inspection citations: the CFR sections that investigators cited on the Form 483 for an inspection. Open a result to see them, or rank them across all inspections in the citation explorer.

FDA states that the database is not a complete list of all inspections and should not be used to compile official data. It leaves out inspections by states, pre-approval inspections, mammography facility inspections, inspections still waiting for a final enforcement action, and inspections of nonclinical laboratories. Treat a missing inspection as unknown.

FDA investigators write down conditions they judge objectionable while they inspect a site. FDA lists them on a Form FDA 483 when, in the investigator's judgment, the conditions or practices indicate that a regulated product may violate FDA's requirements. FDA describes this on its inspection observations page. The investigator lists observations in order of risk significance.

The firm gets the form at the end of the inspection. FDA encourages a written response with a corrective action plan within 15 days, and weighs the response when it decides whether to act. The Form 483 response entry covers what that response contains.

A 483 lists observations. It does not say how serious FDA found them overall. That judgment is the classification below, and it comes weeks later. A 483 with many observations can end as VAI. A short one can end as OAI.

The classification is FDA's conclusion after it has reviewed the inspection report, any Form FDA 483 and the firm's response. FDA usually sends the firm the final classification within 45 to 90 days of the close of the inspection, depending on the inspection type.

• NAI, No Action Indicated. The facility is in an acceptable state of compliance. It usually did not receive a Form 483.
• VAI, Voluntary Action Indicated. FDA observed objectionable conditions or practices and judged that the facility can correct them voluntarily without a recommended action. It usually received a Form 483.
• OAI, Official Action Indicated. The facility is in an unacceptable state of compliance. It is the classification that can precede a warning letter, an import alert or the withholding of pending applications.

The classification is a different thing from the Form 483. The 483 is the list of observations handed over at the close of the inspection, and the classification comes later. Read the Form 483 response entry for what the firm does in between.

Investigators do not write each observation from scratch. FDA keeps a database of standard citations. Each has a CFR reference, a short description and a long description, and the investigator adds the specifics of what was seen. FDA says that several citations can exist for one CFR reference. That is why 21 CFR 211.192 appears under several short descriptions in this data, and why the explorer counts inspections, not rows.

• Count inspections, not citations. One inspection can carry five citations. The explorer reports how many inspections cite a reference, and what share of inspections with posted citations that is.
• The share is among inspections that have posted citations. It is not a share of all inspections, and it is not the chance that an inspection cites the reference.
• A reference is a paragraph. 21 CFR 211.22(d) and 21 CFR 211.22(a) are separate lines because FDA posts the paragraph.
• Frequency is not severity. A reference cited in 30% of inspections is common. It may still be minor. The OAI rate shown with each reference is a rough signal of seriousness, and it reflects which sites get cited as much as what the reference means.
• Device citations changed on 2 February 2026. The Quality Management System Regulation took effect that day and FDA now cites clauses of ISO 13485:2016, not the old 21 CFR 820 sections. A trend line for a section such as 21 CFR 820.100 ends there. Read the 21 CFR 820 entry for the rule itself.

Firm

The legal name of the inspected establishment, with its city, state and country.

FEI number

FDA Establishment Identifier. One number per facility. It follows a site through name changes and is the join to its warning letters and compliance actions.

Inspection end date

The day the inspection closed. The classification arrives later.

Fiscal year

FDA's fiscal year, which runs from 1 October to 30 September and is named for the year it ends in. An inspection ending on 23 October 2026 is in fiscal year 2027.

Classification

NAI, VAI or OAI, with FDA's description.

Product type

Drugs, Devices or Biologics here.

Project area

FDA's program for the inspection, such as Drug Quality Assurance, Blood and Blood Products, Compliance: Devices or Bioresearch Monitoring.

Posted citations

Whether FDA has published the cited CFR references from the inspection. Yes means observations were made, and the result lists them. No does not mean the inspection was clean.

Cited references

The CFR section or ISO 13485 clause on each observation, with FDA's short and long description. Shown under a result when FDA posted them.

• By firm. Enter the name as FDA records it, which is usually the legal name. Try the short form first.
• By classification. Pick OAI to see the inspections that ended in the most serious outcome. Pick VAI to see where FDA found problems it expected the firm to fix itself.
• By product type. Drugs, devices or biologics.
• By fiscal year. A four-digit fiscal year.
• By country. The country of the site, which is the way to review a foreign supplier or contract manufacturer. Try OAI drug inspections in India.

Fields combine, and results come back newest first, 25 to a page. Each search has its own address, so you can link it in a report.

Read the classification, then the history. One NAI says the site was acceptable on that day. A run of VAI results at the same FEI number says FDA keeps finding problems it expects the firm to fix. An OAI followed by another OAI may mean the fix did not hold.

Match the FEI number. Names change after a merger or a sale. The FEI number does not. Use it to find the same site in the warning letter search and the recall search.

Expect a gap after the inspection. The classification is posted after FDA finishes its review, so an inspection that closed a few weeks ago may not be in the data.

Look for what the inspector saw.Where FDA posted citations, the result has a "cited references" line. Open it for the CFR sections and FDA's descriptions. FDA warns that posted descriptions may not match the citations in the final classification letter, and may differ from the Form 483 the firm got.

The Establishment Inspection Report holds the investigator's full account and is available by FOIA request, not in this data. The glossary also covers inspection readiness and the pre-approval inspection.

• It is not complete. FDA says so. State inspections and pre-approval inspections, among others, are not in it.
• The citations are partial. FDA says not all inspections and their citations are in the data, and it posts citations only once every project area of the inspection is classified. The firm's response and FDA's reasoning are not here.
• Some 483s are missing.The citations come from FDA's electronic inspection tools. FDA notes that some 483s are written by hand, and that edits made to a form outside the tools do not reach the data.
• It lags. Classifications appear after review, and the data block above shows the end date of the newest inspection in it.
• A good result is not a guarantee. NAI describes one inspection of the areas FDA covered.
• Names are inconsistent. A firm can appear under several legal names. Search by FEI number when you have it.

FDA's Inspections Data Dashboard. FDA's Inspection Classification Database page explains the data and links to the dashboard, which shows the same classifications.

The Data Dashboard API.FDA offers an API for the dashboard datasets. It requires credentials from FDA's OII Unified Logon. That is why this tool queries it through our own server route and not from your browser.

FDA's yearly observation spreadsheets. FDA publishes, by fiscal year, how many times each reference was cited on its system-generated 483s, in the inspection observations downloads. They are totals with no firm names. From fiscal year 2018 to 2025 the citations here come to 74% to 89% of FDA's count for drugs and 83% to 97% for devices, and the same references lead the list.

Our data files. The snapshot behind the explorer is public at /data/inspection-citations.json, and the analysis of the most cited observations carries a CSV and the script that produced it.

FOIA. Establishment Inspection Reports and the Form 483 for a specific inspection are available through a Freedom of Information Act request to FDA.

What do NAI, VAI and OAI mean?

No Action Indicated means no objectionable conditions were found, or none warranting action. Voluntary Action Indicated means objectionable conditions were found but not at a level warranting formal action. Official Action Indicated means conditions warranting formal regulatory action, and it is the classification that precedes a warning letter, an import alert or withholding of pending applications.

Is the classification the same as a Form 483?

No. The Form 483 is the list of observations left at the close of the inspection. The classification is FDA's conclusion afterwards, recorded in the Establishment Inspection Report. A long 483 classified VAI is a better outcome than a short one classified OAI, and you cannot tell which you have from the 483 alone.

What is an FEI number?

The FDA Establishment Identifier, a unique number for a facility. It is the join between a site's inspection history and any warning letters issued to it.

What does 'citations posted' mean?

That FDA has published the CFR references cited on the inspection's Form 483. Open the result to read them. A result with no posted citations may still have had observations: FDA posts citations only once every project area of the inspection is classified, and not for every inspection.

What are the most common FDA 483 observations?

For drugs, the most cited references in recent years are 21 CFR 211.22(d), quality unit procedures not in writing or not followed, and 21 CFR 211.192, investigation of discrepancies and failures. For devices, 21 CFR 820.100(a), corrective and preventive action procedures, and 21 CFR 820.198(a), complaint handling procedures. The tables on this page rank them for the latest complete fiscal years from FDA's posted citations.

Is a Form 483 searchable?

The cited CFR references and FDA's descriptions are. The full Form 483 is not in this data. FDA publishes some 483s in its electronic reading room, and the rest are available through a FOIA request.

Why do device inspections cite ISO 13485 now?

The Quality Management System Regulation took effect on 2 February 2026. It incorporates ISO 13485:2016 into 21 CFR Part 820, and FDA's inspection process changed the same day. Device observations written since then cite ISO 13485 clauses, so counts for the old 820 sections stop at that date.

How current is this?

It queries FDA's Data Dashboard, which FDA says it updates weekly, so results are as current as FDA's own dataset. Classifications appear after the inspection is closed, usually 45 to 90 days later, so a recent inspection may not be classified yet. The data block on this page shows the end date of the newest inspection.

Is the FDA inspection database complete?

No. FDA says it is not a comprehensive list of inspections. State inspections, pre-approval inspections, mammography facility inspections, inspections awaiting a final enforcement action and nonclinical laboratory inspections are not in it.

Is there an API or bulk download for FDA inspections?

FDA's Data Dashboard has an API, but it requires credentials from FDA's OII Unified Logon, so this tool calls it through our own server. FDA also publishes the dashboard itself, which shows the same classifications.

Why only drugs, devices and biologics?

FDA's dataset covers all product types. Food and tobacco are the majority and none of it concerns a life sciences reader, so the scope is drugs, devices and biologics. The data block on this page gives the current count.