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Global Observations
US FDA Observation Trends
The US FDA has been posting summaries of global 483s since 2006. Click the blue button below and scroll down on the US FDA webpage to access the Excel file download.
US FDA Global Observation Trends
U.S. FDA Domestic vs. Foreign Compliance Actions (Drug Quality Assurance) 2009 – Current*
>9873 Compliance Actions
- U.S.A.
2468 - 9873 Compliance Actions
- Canada, UK, Spain, France, Germany, India, China, Australia, Taiwan, Indonesia, Japan
987 - 2468 Compliance Actions
- Mexico, Brazil, Sweden, Denmark, Netherlands, Switzerland, Israel, Vietnam, Malaysia, Philippines
% Predominant Overseas Active Pharmaceutical Ingredients (API) Contributors to the US Market in 2018
- India 31%
- EU Countries 31%
- China 14%
- USA 12%
- Rest of World 11%
- Latin America 2%
India was # 1 Overseas FDF Contributor in 2018.
Predominant Overseas Finished Dosage Forms (FDF) Contributors - 2018 as reported by the U.S. FDA Drug Shortage Task Force 2019.
- India (24%)
- EU Countries (18%)
- China (8%)
- Canada (4%)
Regional Distribution of Facilities Manufacturing Finished Dosage Forms (FDF) in 2018. These numbers apply to manufacturers named in approved applications. Medical gas, compounding, pending application, and non-application (OTC) facilities are excluded. Percentages have been rounded.
All drug manufacturing sites for the U.S. market by country for FY 2018*
1: U.S. (39% Sites)
2: India (12%) Sites
3: China (11%) Sites
4: Germany & South Korea (4%) Sites
Drug Quality Inspections for Manufacturing Sites for FY 2018 by Country*
1: U.S. (47%)
2: India (13%)
3: China (9%)
4: Germany (4%)
5: Canada, Japan, and Italy (3%)
6: South Korea, France, Switzerland (2%)