谁能看到483表，并且从什么地方获取？？？？

beiwei5du

Who can see Form FDA 483s, and where do I get them?

by Tony Chen
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 (and here’s who you write to).  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the Freedom of Information office to be professional, courteous, and hard-working, though I suspect they are bound by outdated technology.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 250 Form FDA 483s in the biotech and pharma industries.  We charge $39 for individual 483, but also offer some special bundles.  Visit our Form FDA 483 store – you’ll get the reports instantly, anonymously, and economically.
Find out more about how FDAzilla can help you work smarter with FDA data.  Get access to unlimited 483s with the 483 subscription. Access inspection and inspector data with Enforcement Analytics. Get weekly GMP regulatory surveillance in your inbox with GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.

理论上任何人都能够通过信息自由法案获取到483表，但是FDA会按照46美元/小时收取相应的费用，如果该483表是初次被要求，那么有时候可能会在你拿到483表前耗费你大量的费用。如果该483表不属于初次要求被公开，那么这个时间会相应的缩短（有时可能被被按照46没有（即1小时）的费用收取）。但是注意一个有趣的问题，你向FDA索取483表的要求也属于公共信息，我们最近向FDA咨询谁在索求这些483表，我们发现很多都是都是大量公司（索取竞争对手公司），投资公司，大的新闻传媒公司，工会，个人和其他。

msdorothychen

好帖顶一顶！