FAQ: “Why Do You Sell FDA 483s? Aren’t they free?”

Good question, I’m glad you asked!

It’s true that the FDA releases FDA 483s on their ORA FOIA Reading Room. However, these represent only the most frequently requested 483s. In fact, if you look over the years, there are probably close to 100,000 FDA 483s sitting somewhere on an FDA server.  They release only a few a week.

FDAzilla requests many additional FDA 483s from the FDA.  Our database is getting close to 5,000 FDA 483s, one of the largest in existence.  We then utilize custom software that we have developed over the years to tag each FDA 483 by inspector, inspection, site, inspection date, and other relevant data elements.  This tagging enables you to search 483s by any of these data elements in the FDAzilla 483 store.

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

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