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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 05 February 2014 | By Alexander Gaffney, RAC
US regulators performed fewer inspections in 2013 than at any time in the previous five years, according to a new analysis released this week.
The analysis, performed by FDAzilla, a business which tracks and sells FDA inspections and reports, found that the agency performed 37,774 inspections in 2013.
While numerically impressive, it was nevertheless a five-year low, the report noted.
"It's the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522)," wrote Tony Chen, co-founder of FDAzilla.
In fact, an analysis of all inspection data going back to 2004 shows that FDA performed fewer inspections in 2013 than in any other year except for 2008.
It's also a 7.8% decrease from the year prior, and significantly below its 2011 high of 46,241 inspections.
While it's difficult to discern a reason for the drop from the data alone, it could be attributed to cuts in FDA's budget due to the Budget Control Act. Under the Act, FDA lost access to approximately $318 million in funding. Without that funding, FDA may have needed to cut back on the frequency of its inspections.
Jan
3,755
3,532
3,657
3,623
3,569
3,403
3,419
3,561
3,910
3,760
Feb
3,644
3,630
3,717
3,424
3,549
3,675
3,726
3,711
4,011
3,754
Mar
4,518
3,956
4,352
3,944
3,714
4,200
4,852
5,066
4,658
4,123
Apr
3,789
3,208
3,420
3,255
3,388
3,733
4,098
3,674
3,771
3,888
May
3,595
3,263
3,788
3,813
3,487
3,504
3,874
4,030
4,054
3,845
Jun
3,506
3,691
3,635
3,688
4,040
4,358
4,400
3,839
3,536
Jul
3,285
2,889
2,820
3,109
3,612
3,715
3,206
3,441
3,273
3,312
Aug
3,709
3,611
3,642
3,381
3,700
4,406
3,770
3,563
Sep
3,727
3,444
3,442
3,294
3,362
3,954
3,368
3,713
3,187
3,003
Oct
3,636
2,398
2,714
2,736
2,463
2,656
2,843
2,871
2,673
2,081
Nov
3,455
3,197
3,244
3,059
2,637
3,079
3,712
2,996
2,614
Dec
3,031
2,835
2,582
2,798
3,078
3,656
2,999
2,286
43,825
39,850
41,163
39,855
39,522
42,569
44,374
46,241
43,141
39,765
*Includes all inspections, including Food and Tobacco.
Tags: Latest News, inspections