FDA drug inspections by the numbers

FDA investigators carried out 1,248 drug quality inspections in fiscal 2025, the year that ended September 30, 2025. That was the most since fiscal 2019 and nearly five times the pandemic low of 259 in fiscal 2021, according to the agency's fiscal 2025 Report on the State of Pharmaceutical Quality¹ and its fiscal 2024 edition².

Fiscal 2025 also broke a pattern. For the first time since fiscal 2022, more of those inspections took place in the US (702) than abroad (546). And the US plants fared worse. Of the inspections at US sites, 21.6 percent ended in Official Action Indicated, FDA's most serious classification, against 8.0 percent in China and 18 percent worldwide.

Inspection counts are one of the few hard measures of how closely FDA watches the factories behind American medicine, and they have swung widely over the past seven years. GxRadar compiled the numbers from FDA's annual quality reports, its generic drug user fee report to Congress and its public classification rules.

Seven years of drug quality inspections

FDA counts "drug quality assurance" inspections, which it defines as surveillance and for-cause inspections run under its main drug manufacturing compliance program. Pre-approval inspections tied to pending applications fall under a different program and are not part of this count. The table below combines the two most recent reports, which FDA posts on its State of Pharmaceutical Quality page³.

Totals and US counts are from FDA's fiscal 2024 and 2025 reports. Outside-US figures are GxRadar's subtraction, which matches the fiscal 2025 report's own split for 2024. The fiscal 2024 report's text gives slightly higher foreign counts for 2022 through 2024 (146, 397 and 555), so treat the earlier rows as close approximations.

Inspections fell sharply during the COVID-19 public health emergency, which the report dates from January 27, 2020, to May 11, 2023. In fiscal 2021, FDA inspected 22 drug plants outside the US.

FDA picks sites for surveillance visits with a risk model. Its description of that model⁵ lists the facility type, compliance history (including whether a site was inspected in the last four years), recall and other hazard signals, the inherent risk of the product, and whether a foreign regulator has inspected the site. A sterile plant making narrow therapeutic index drugs with no inspection history would rank above a well-known plant making over-the-counter tablets, FDA says.

How FDA grades an inspection

Every inspection ends in one of three final classifications. FDA's inspection classification database page⁴ defines them.

No Action Indicated (NAI) means a facility "is in an acceptable state of compliance," usually with no Form 483 issued. Voluntary Action Indicated (VAI) means investigators found objectionable conditions, but FDA will not recommend action because the firm can fix them on its own. Official Action Indicated (OAI) means the facility "is in an unacceptable state of compliance" and regulatory action may follow. FDA says it usually sends the classification letter within 45 to 90 days of the inspection's close, and it encourages firms to answer a Form 483 within 15 days.

Outcomes by region in fiscal 2025

For fiscal 2025, FDA reported outcomes for 1,309 inspections: its own 1,248 plus 61 by partner regulators under mutual recognition agreements with the European Union, the United Kingdom and Switzerland. Overall, 22 percent were NAI, 60 percent VAI and 18 percent OAI. FDA said a chi-squared test found the differences across regions statistically significant.

Percentages are from Figure 2 of the fiscal 2025 report¹. The OAI counts are GxRadar's estimates (inspections times the OAI share, rounded), and they sum to about 232, close to 18 percent of 1,309.

Those results sit awkwardly beside an FDA statement from May 2025. Announcing an expansion of unannounced foreign inspections⁷, the agency said that despite advance notice, "the FDA still found serious deficiencies more than twice as often than during domestic inspections." That release covered all FDA-regulated products and did not give a time period, so the two figures measure different things. For drug quality inspections in fiscal 2025, the US had the highest OAI rate of any region.

One caution applies to the US numbers. The fiscal 2025 report was the first to add makers of medical gases to FDA's site catalog, and 1,698 of those sites are in the US. The report's inspection counts are not broken out by type of site.

A longer view comes from each site's most recent inspection. As of fiscal 2024, 93 percent of the sites FDA counted (3,823 of 4,103) had a most recent outcome of NAI or VAI. The share ranged from 87 percent in India to 98 percent in Europe, with the US at 92 percent and China at 93 percent, the fiscal 2024 report² said.

Inspections tied to generic drugs

FDA's fiscal 2025 GDUFA performance report⁶ breaks out inspections linked to generic drug applications. Surveillance visits to finished-dose plants were split almost evenly, 106 domestic and 112 foreign. Surveillance visits to active ingredient plants were mostly abroad, 152 of 182. Pre-approval inspections of finished-dose plants numbered 60, of which 43 were foreign. Inspections of bioequivalence clinical sites, where the blood-level studies behind generic applications are run, were 82 foreign and eight domestic.

That report also times the steps. For generic drug inspections in fiscal 2025, the median time from the start of an inspection to a Form 483 was five days. Where the inspection ended in OAI, the median from the 483 to a warning letter was 169 days, to an import alert 144 days, and to a regulatory meeting 168 days. Our explainer on 483s and warning letters covers those steps, our glossary defines an import alert, and our CGMP explainer describes the rules being enforced.

Inspection problems also block approvals. FDA analyzed nearly 10,000 drug applications and supplements received in fiscal 2024 and 2025 that needed a facility assessment. By May 2026, 28 percent had received a complete response letter, and 43 percent of those letters were "facility withholds," more than half involving plants already classified OAI or potentially OAI, the fiscal 2025 report¹ said. Our guide to how a generic drug gets approved covers where that letter falls in the process.

Paper inspections and partner inspections

FDA increasingly evaluates plants without sending anyone. Under section 704(a)(4) of the FD&C Act it can demand the records an investigator would review on site. In fiscal 2025 it used 141 such records reviews to support application decisions, 74 percent sent to foreign manufacturers, led by India (21 percent) and China (12 percent). It also relied on a record 69 partner-regulator inspections to evaluate facilities named in pending applications.

Records requests can lead to import alerts on their own. In fiscal 2024, more than 60 percent of the 75 sites added to drug quality import alerts got there through 704(a)(4) requests, often because the response was deficient or never came, the fiscal 2024 report² said. That same year, drug quality warning letters to US sites fell from 59 to 41 while letters to foreign sites rose from 35 to 64. Our guide to where drug ingredients come from covers the overseas supply base behind those numbers.

What to watch

Recalls are the other public trace of quality failures. GxRadar's recall tracker logged 212 drug recall records from July 30 to October 28, 2026, 19 of them Class I.

Changes to inspection rules for generics are also in the user fee renewal. FDA's proposed GDUFA IV commitment letter⁸ for fiscal 2028 through 2032 would push an application's goal date to 120 days after the inspection closes when a surveillance inspection of a named facility produces a potential OAI alert within 90 days of that date, and would add post-pre-approval-inspection meetings. Current authority expires in September 2027, and new legislation is needed for fees to continue, FDA's GDUFA IV page⁹ says.