Form FDA 483s are central to anyone’s FDA inspection preparation program.
As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?”
This is where things get a little tricky.
Theoretically, Form FDA 483s are public information and, thus, are available through the FDA’s Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone.
That said, requesting a 483 can be costly and may take a lot of time. The FDA must scrub/redact any potentially confidential information from the report before it is released to the public. And the FDA charges $46 per hour for FOIA requests. So, if the Form FDA 483 has not been previously requested, you may end up paying hundreds of dollars and waiting hundreds of days before getting it.
I’ve heard some people say they got their requested 483 2 years after their initial request. Everyone seems to know someone that has experienced this (or maybe it’s the same person who keeps talking about it!).
Form FDA 483s that have already been requested by someone else and, subsequently, processed (thus, already redacted of confidential information) can be turned around quickly – within days or weeks, depending on the backlog at the FDA FOIA office. You’ll likely be charged the minimum of 1 hour of work, or $46, for processing the request.
Also, keep in mind that if you request a Form FDA 483 from the FDA, that request itself is also public information. We recently asked the FDA who has been asking for Form FDA 483s, and you’ll find an interesting list of companies asking for their competitors’ Form FDA 483s, investment companies, major news media companies, worker’s unions, individuals, and a potpourri of others.
All of this said, I’ve always found the Freedom of Information Office to be professional, courteous, and hard-working, though I suspect they are bound by outdated technology. It’s a world of PDFs and manual searching and such, so it’s not like you can strategically search for specific themes or trends.
In contrast, we have over 11,000 Form FDA 483s in our database that are keyword tagged, searchable, cross-referenced for easy comparison, and easy to copy/paste/print.
With a subscription to our Enforcement Analytics platform, not only do you have access to all of the 483s in our database, but you also have the power to run macro trend reports, monitor your CMOs/suppliers, investigate your inspector, and more with just a few clicks.
Or, if you prefer, you can also purchase individual 483s for $119 in our document store to get the reports you need instantly, anonymously, and economically.
Want to see what else we can do with FDAzilla Enforcement Analytics? Check out our Video Tour here.
FDAzilla 483s Resource Center:
- A Bad 483 Could Cost A Company Millions
- To Understand Data Integrity, Just Read These 6 FDA 483s
- 5 Features To Look For In A Form 483
- Where Form FDA 483s begin: 3 Types of FDA Inspections
- What’s the big deal about these Form FDA 483?
- Who can see Form FDA 483s, and where do I get them?
- How to Respond to a Form FDA 483
- What have you learned from reading Form FDA 483 observations?
Header Image Provided By FOIA.gov
About the Author
Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.