2013 Saw Plunge in FDA Inspections, Second Fewest in Last Decade

Posted 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.

Total FDA Inspections* by Month

2004200520062007200820092010201120122013

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

3,532

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

3,255

3,532

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

3,424

3,712

2,996

2,614

Dec

3,206

3,031

2,835

2,582

2,798

3,078

3,506

3,656

2,999

2,286

Yearly Totals

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.


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