FDA Inspections Map

Where in the world FDA inspects the factories that make US drugs and devices, and how often it finds problems serious enough to act on.

Drug, device and biologic inspections that ended Oct 29, 2025 to Oct 29, 2026 and that FDA has classified, by the country of the site. A country is shaded by the share FDA classified Official Action Indicated, its most serious outcome.

Inspections: 3,712
OAI overall: 4.3%
Outside the US: 814 in 51 countries

By Country

Most inspections first. OAI counts open the inspections.

Site country	Inspections	OAI	OAI share
United States	2,898	107	3.7%
India	163	18	11%
China	124	6	4.8%
Germany	54	1	1.9%
Japan	49	5	10%
Canada	40	1	2.5%
Italy	35	2	5.7%
France	34	1	2.9%
Korea (the Republic of)	33	5	15%
United Kingdom	30	1	3.3%
Spain	27	0	0.0%
Taiwan	25	3	12%
Poland	23	0	0.0%
Switzerland	18	0	0.0%
Argentina	16	2	13%
Netherlands	14	0	0.0%
Sweden	10	0	0.0%
Bulgaria	9	0	0.0%, few inspections
Denmark	8	0	0.0%, few inspections
Belgium	8	1	13%, few inspections
Australia	7	1	14%, few inspections
Turkey	7	1	14%, few inspections
Brazil	6	0	0.0%, few inspections
Austria	6	0	0.0%, few inspections
Singapore	6	0	0.0%, few inspections
Mexico	6	1	17%, few inspections
South Africa	5	1	20%, few inspections
Ireland	5	1	20%, few inspections
Thailand	4	0	0.0%, few inspections
Hungary	4	0	0.0%, few inspections
Chile	4	0	0.0%, few inspections
Serbia	3	0	0.0%, few inspections
Greece	3	1	33%, few inspections
Malaysia	3	0	0.0%, few inspections
Costa Rica	2	0	0.0%, few inspections
Georgia	2	0	0.0%, few inspections
Lithuania	2	0	0.0%, few inspections
Dominican Republic (the)	2	0	0.0%, few inspections
Philippines	2	0	0.0%, few inspections
Macao	2	1	50%, few inspections
Slovenia	2	0	0.0%, few inspections
Indonesia	1	0	0.0%, few inspections
Romania	1	0	0.0%, few inspections
Estonia	1	0	0.0%, few inspections
Portugal	1	0	0.0%, few inspections
Cuba	1	0	0.0%, few inspections
Iceland	1	0	0.0%, few inspections
Vietnam	1	1	100%, few inspections
Finland	1	0	0.0%, few inspections
Cambodia	1	0	0.0%, few inspections
Senegal	1	0	0.0%, few inspections
Czech Republic	1	0	0.0%, few inspections

Show all 52

Each inspection counts once, by the date it ended and the country of the inspected site; FDA classifies an inspection weeks to months after it ends, so the newest months are still filling in. NAI means no action indicated, VAI voluntary action indicated, and OAI official action indicated, which can lead to a warning letter, import alert or refused approvals. Refreshed daily. FDA Data Dashboard, inspection classifications

Share of Inspections Classified OAI, by Site Country

By Country