Previously, we talked a bit about what the big deal is about these Form FDA 483s. Today, we talk about how to get a hold of actual 483 reports and who else can see them. This is where things get a little more tricky. Theoretically, Form FDA 483s are public information and, thus, available through the FDA’s Freedom of Information Act Office. So, any Form FDA 483 can be requested by anyone. However, 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 two 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. 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the Freedom of Information Office to be professional, courteous, and hard-working, though I suspect they are bound by outdated technology.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.
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.
FDAzilla offers almost 7,500 Form FDA 483s. We charge $119 for individual 483s, but also offer some special services. Visit our Form FDA 483 store – you’ll get the reports instantly, anonymously, and economically.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at firstname.lastname@example.org
FDAzilla 483s Resource Center:
- Form FDA 483s: 3 Types of Inspections
- What’s the big deal about these Form FDA 483?
- How to Respond to a Form FDA 483
- What have you learned from reading Form FDA 483 observations?
- Form FDA 483s listings