Where Overseas FDA Inspections Took Place
1 CommentBy Ed Silverman // February 15th, 2008 // 1:24 pm
Since the beginning of the federal government’s fiscal year 2002, the FDA conducted approximately 1,379 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns. The table below contains the number of inspections conducted by the FDA in the 10 countries with the highest number of pharmaceutical facilities inspected. Notice the number for China. (These numbers were provided by the FDA to the Senate Finance Committee).
| Country | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | Total |
|---|---|---|---|---|---|---|---|
| India | 10 | 19 | 36 | 33 | 34 | 61 | 193 |
| Germany | 23 | 14 | 35 | 25 | 20 | 18 | 135 |
| Italy | 16 | 31 | 25 | 21 | 17 | 12 | 122 |
| Canada | 27 | 12 | 17 | 22 | 24 | 16 | 118 |
| U.K. | 17 | 22 | 17 | 18 | 16 | 9 | 99 |
| France | 14 | 18 | 13 | 12 | 15 | 24 | 96 |
| Japan | 10 | 13 | 13 | 21 | 13 | 12 | 92 |
| China | 11 | 6 | 18 | 13 | 16 | 11 | 76 |
| Switzerland | 11 | 11 | 11 | 15 | 9 | 14 | 71 |
| Ireland | 11 | 5 | 12 | 14 | 2 | 7 | 51 |
fdanews
It’s widely known that foreign inspections are primarily “pre-approval” inspections. So your inference that FDA inspects facilities in areas where quality is not typically an issue is wrong. Foreign inspectional assignments are merely responses to NDA/ANDA applications submitted by industry. Occasionally, there is the need for a “for cause” inspection, which is what we are sseing with heparin.