Data views / FDA inspection outcomes by country

FDA inspection outcomes benchmarked by country

16 records Updated 9 July 2026

Across 937 inspected suppliers, this is the share carrying at least one OAI classification, by country of headquarters. Countries with fewer than ten inspected suppliers are excluded.

All 16

CountryInspected suppliersWith an OAIOAI shareHolding a US DMF
India 1983719%149
China 197179%174
United States 1734325%56
Germany 6123%22
Italy 57611%33
France 5136%17
Japan 33618%27
Spain 32413%14
Switzerland 2827%15
United Kingdom 2300%11
Taiwan 18317%13
Canada 17212%6
Ireland 1616%4
Brazil 12217%9
Mexico 1119%2
South Korea 10110%7

Where these figures come from

Every number on this page is counted from published registers — nothing is modelled or estimated. Records last refreshed 9 July 2026. How we count our figures.

Source
FDA inspection classifications
Source
FDA, List of Drug Master Files

Questions

What does the OAI share mean?
The proportion of that country's inspected suppliers that carry at least one Official Action Indicated classification. It is a share of inspected suppliers, not of all suppliers, so countries whose sites are inspected more often are not penalised for that.
Why exclude countries with under ten suppliers?
With a handful of suppliers a single OAI swings the share by tens of percentage points, which reads as a country-level signal when it is one site. The threshold keeps the comparison honest.
Is a low OAI share proof of quality?
No. It reflects published outcomes for sites the FDA has inspected. Sites never inspected do not appear at all, so this measures the inspected population rather than the whole country.

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