Statistics

FDA clinical investigator inspections by year and classification

Counted from the FDA Bioresearch Monitoring inspection record for drug and biologic clinical research — clinical investigators (the large majority), sponsors, CROs and IRBs — from fiscal year 2009 to 2026. FDA’s fiscal year runs October to September. Every inspection is classified after review as NAI (No Action Indicated), VAI (Voluntary Action Indicated) or OAI (Official Action Indicated), the most serious inspection classification FDA assigns; what they mean is explained at OAI, VAI and NAI.

11,960

inspections classified, FY2009–2026

9,029

distinct facilities inspected

351

classified OAI (2.9% of inspections)

6,693

findings FDA cited at them

192

warning letters

Inspections and classifications by fiscal year

Fiscal year	Inspections	NAI	VAI	OAI	OAI share	Warning letters
FY2009	750	367	330	53	7.1%	15
FY2010	652	312	303	37	5.7%	26
FY2011	604	319	247	38	6.3%	16
FY2012	647	351	273	23	3.6%	14
FY2013	618	351	233	34	5.5%	10
FY2014	742	439	282	21	2.8%	13
FY2015	716	431	261	24	3.4%	4
FY2016	671	461	194	16	2.4%	9
FY2017	789	548	230	11	1.4%	7
FY2018	815	604	206	5	0.6%	1
FY2019	735	556	171	8	1.1%	5
FY2020	469	372	92	5	1.1%	2
FY2021	528	402	115	11	2.1%	8
FY2022	562	434	115	13	2.3%	7
FY2023	702	543	138	21	3.0%	11
FY2024	726	548	160	18	2.5%	12
FY2025	680	533	134	13	1.9%	19
FY2026	554	439	115	0	0.0%	13
All years	11,960	8,010	3,599	351	2.9%	192

Inspections are counted by the fiscal year FDA assigns them. FDA classifies an inspection weeks to months after it closes, so the most recent one or two fiscal years are still filling in — and because OAI classifications take the longest to finalize, the newest years understate OAI most. The warning-letter column counts the warning letters FDA issued to the same facilities in that fiscal year; a warning letter usually lands in the fiscal year after the inspection that led to it.

How to read the trend

Two things stand out in most years of this record. The share of inspections classified OAI is small — a few percent — and it has fallen from the early years of the record, while NAI has grown as a share. And the volume of inspections dropped sharply in fiscal 2020 and 2021 and has since recovered toward its earlier level. Neither fact says anything about a particular site; the figures are a benchmark for reading one clinical investigator’s record against the field, which is the last of the six checks in clinical investigator vetting.

The regulations FDA cites most

Across the 6,693 findings FDA has cited at these inspections, the ten most-cited provisions. Each finding is one cited regulation from one inspection; an inspection can carry several.

Regulation	FDA’s short description	Findings
21 CFR 312.60	FD-1572, protocol compliance	2,137
21 CFR 312.62(b)	Case history records- inadequate or inaccurate	1,162
21 CFR 312.62(a)	Accountability records	368
21 CFR 312.66	Unanticipated problems	303
21 CFR 312.50	General responsibilities of sponsors	259
21 CFR 56.115(a)(2)	Minutes of IRB meetings	219
21 CFR 56.108(a)(1)	Initial and continuing reviews	189
21 CFR 312.64(b)	Safety reports	170
21 CFR 50.27(a)	Consent form not approved/signed/dated	151
21 CFR 56.115(a)(5)	List of members	118

A regulation can carry more than one kind of finding; the description shown is the one FDA used most under it. Conducting the study (21 CFR 312.60) and case histories (21 CFR 312.62(b)) lead in every year; together they account for a large share of everything FDA cites at a clinical investigator. The areas one by one, and how the mix has changed: clinical investigator deficiencies. What the leading findings look like in a warning letter: warning letters to clinical investigators.

Disqualification and debarment

232

clinical investigator disqualification proceedings on record

144

of them ending in disqualification

152

persons on FDA’s debarment list

Both lists are small against 11,960 inspections — which is the point: the great majority of clinical investigators with a history appear on neither, because their record lives in the inspections, findings and warning letters above. The two mechanisms and how they differ: debarment vs. disqualification; the proceeding itself: NIDPOE and NOOH letters.

What is counted, and what is not

Counted. FDA Bioresearch Monitoring inspections of clinical investigators, sponsors, sponsor-investigators, CROs and IRBs for drug and biologic clinical research (CDER and CBER), as classified by FDA; the findings FDA cited at those inspections; and warning letters issued to the same facilities.

Not counted. Bioequivalence, GLP, postmarketing adverse drug experience and REMS inspections; device trials; veterinary products; and inspections FDA has closed but not yet classified.

Currency. The record is checked daily and rebuilt whenever new FDA information is available; the date of the latest check is in the footer. Figures on this page are recomputed at each rebuild.

Questions this page answers

How many clinical investigator inspections does FDA conduct each year?

In the record for drug and biologic clinical research, FDA has closed and classified roughly 500 to 750 Bioresearch Monitoring inspections a year in most fiscal years, the large majority of them of clinical investigators; fiscal 2020 and 2021 were lower. The table above gives the count for every year since 2009.

What percentage of FDA clinical investigator inspections are classified OAI?

A few percent. Across the record about 2.9% of inspections were classified Official Action Indicated, with the share higher in the early years of the record and lower recently. Most inspections are NAI; roughly a third are VAI.

Why do the most recent years show fewer inspections and fewer OAIs?

Because an inspection is classified only after the reviewing center has evaluated it, weeks to months after it closes, and OAI decisions take the longest. The newest one or two fiscal years are still filling in and will rise as classifications are assigned.

What does FDA cite most often at clinical investigator inspections?

Not conducting the study in accordance with the signed investigator statement and the investigational plan (21 CFR 312.60) and inadequate or inaccurate case histories (21 CFR 312.62(b)) are the most-cited provisions in every year, followed by investigational-drug disposition records, reporting of unanticipated problems to the IRB, informed consent, and, for sponsors, general sponsor responsibilities (21 CFR 312.50).

Where do these numbers come from?

From the FDA Bioresearch Monitoring inspection, findings, enforcement, disqualification and debarment records, assembled and counted by Clinical Precedent. Clinical Precedent is independent of FDA; nothing here is an FDA determination.

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Counts are aggregate and carry no identifying information. Related: OAI, VAI and NAI · FDA inspections of clinical investigators · FDA’s clinical investigator inspection lists · what is clinical investigator vetting?