The FDA ended 2013 with 39,774 inspections – a 5-year low. It’s the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522). We’ve updated our FDA inspections/483s database through early January 2014. Check out the new data here>>
It’s hard to say what is driving the big drop this year (8% drop from last year). First instinct is to blame the government shutdown, but the data shows a drop throughout the entire year, not just October 2013. There have been some rumblings that inspections are getting longer/tougher/more involved, but those rumors are still unsubstantiated. Digging deeper, there are more resources being diverted to building inspection capacity overseas – could this be a reason also? What do you think?
FEBRUARY 6, 2014 UPDATE: Some readers have aptly pointed out that one possible reason for the drop was the sequestration. Steve Grossman, of FDA Matters, pointed out last year: “To absorb the $209 million without furloughs, most of the savings will have to come from unfilled and/or delayed filling of vacancies—a process that probably started months ago. Many offices are probably already short-staffed and most will become so as we get deeper into the sequester. Hence, the predicted impact of the sequester is slowdowns in food (and other) inspections, drug and device reviews, and implementation of new FDA legislation and its global responsibilities.” It was also reported in USAToday that Commissioner Hamburg expected 2,100 less food inspections in 2013.
You can purchase the entire list of inspections and FDA 483s for $569. Buy list for $569>>
The list contains these fields:
- FEI Number
- Inspection Start Date
- Inspection End Date
- Legal Name
- State Code
- Zip Code
- Country Name
- Full Name
- Accomplishing Org
- Letterhead Name
The spreadsheet is 80MBs. Please note that inspections with more than one inspector (or CENTER) will be listed on 2 separate rows.
Other FDA 483 resources