As the keeper of the world’s largest database of FDA 483 reports (other than the FDA itself), we often get asked, “Where can I find FDA 483 reports, and who else can see them?”

This is where things get a little tricky.


Let’s first be clear that while FDA publishes a subset of the FDA 483 public record on its website, not all 483s are published there for easy access. If you want to see any unpublished 483, you have to make a special request, which takes time and money.

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. Currently, the FDA charges $29, $58, or $102 (depending on the level of the FDA employee fulfilling the request), a duplication fee of $0.10 per page, and $10 for each certification. The FDA must also take the time to scrub/redact any potentially confidential information from the report before it is released to the public.

So, if the specific Form FDA 483 has not been previously requested, you may end up paying hundreds of dollars and waiting hundreds of days before getting it.

We’ve heard some people say they got their requested 483 two years after their initial request. Everyone seems to know someone who has experienced this (or maybe it’s the same person who keeps talking about it!).

Of course, if you want instant access to nearly any recent 483 (or 483R or EIR), you can get it through the Redica Systems Document Store (formerly fdazilla.com) or by having your life sciences company become a Redica Systems subscriber. Subscribers can access these enforcement documents, plus much more, including advanced Quality and Regulatory Intelligence, showing you aggregated stats and trends based on all of the documents collected worldwide.

If you think your company may be interested in a subscription, feel free to request a demo here.

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 a minimum of one hour of work, or $46 (at the time of writing), 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, we’ve always found the Freedom of Information Office to be professional, courteous, and hard-working, though we 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.

The FDA makes published 483s available through its CDER FOIA Electronic Reading Room and ORA FOIA Electronic Reading Room. The FDA also offers the FDA Inspection Observations page, which supplies statistics on 483s that the agency has issued using automation, but not those that were manually prepared.

If you want additional info on FDA 483s to help you answer your question “where can I find FDA 483 reports?”, these posts will help you:

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