FDA Inspections Database is Now Available

We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details.

 

 

Some observations from a brief glance into the data:

  • There are 225,000+ inspections in the database
  • Feel bad for these 20 companies that had inspections end on December 31, 2012. Feel worse for these 4 companies that had inspections end the day after that.
  • Which month are you most likely to get inspected? Hard to say, but we do know that March was the month that averaged the most – more than 4,400+ per month. The only other month over 4,000+ was June.
  • Looks like they may be some lag in the data gathering on the FDA end of things, as the 2013 numbers look ridiculously (50-75%) low.
  • 250 inspections ended up March 10, 2011

For the inspections that resulted in a 483 that we happen to have, you’ll also see a button linking to the 483 in our store. See below for an example.Buy 483 button

Additionally, as you can see above, FDA inspections that resulted in a 483 are notated with a red “x”. FDA inspections that did not result in a 483 are notated with a green check mark.

If you’d like a download (in excel format), we have the 2012 spreadsheet as well as the 2010 through June 2013 spreadsheet available here.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

Other 483 Resources

 

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