FDA 483s Resource Center

Resources to Avoid & Respond to FDA 483s

Form FDA 483s.  If you’re part of the very small fraternity of people who have “FDA 483s” in your vocabulary, this website is for you.  Please see our list of most helpful resources all about FDA 483 Letters.

We welcome you to add to this list by submitting your links here.  We’ll credit you as the source, if you’d like, or keep your contribution anonymous.  The goal is to bring more transparency and mutual sharing/learning on Form FDA 483s so that you can work smarter with the FDA.

FDA 483s 101

1. FDA 483s (Wikipedia).  The best 101 (and beyond) for understanding Form FDA 483s.
2. FDA website ORA Reading Room.  The FDA makes available Form FDA 483s that are “frequently requested”.  Though these Form FDA 483s only make up a small percentage of all their Form FDA 483s, it is helpful to check this page often for updates (updated 1-2 times/month).
3. Where Form FDA 483s begin: 3 Types of FDA Inspections (FDAzilla Blog).  While being ready looks the same no matter what type of inspection occurs, it’s still helpful to understand what the FDA is specifically looking for.
4. What’s the big deal about these Form FDA 483? (FDAzilla Blog). “483s” are the industry shorthand for “Form FDA 483s”, the official inspection report that documents FDA inspector observations of manufacturing facilities.  A response from the inspected company is not required, but strongly encouraged.
5. Who can see FDA 483s, and where do I get them? (FDAzilla Blog) Anyone can request 483s from the FDA through the Freedom of Information Act.  But it usually takes longer than you might expect.  Keep in mind that your request is in itself public information, so people can find out what you’re poking around for.
6. 5 Features to Look for in an FDA Form 483.  Now that you know what the FDA is looking for, here is what you should be looking for in a 483.
7. 5 Features to Look for in a Warning Letter.  And, what you should be looking for in a warning letter (even if it’s, hopefully, not yours).
8. 5 Features to Look for in an EIR.  And, finally, what you should look for in an Establish Inspection Reports (EIR).
9. A while back, we asked for the list of people who asked for anything related to the FDA – this 483s FOIA Info PDF is the result.  In 1 year, the FDA processed roughly 1,300+ 483-related FOIA requests.
10. How to Respond to a Form FDA 483 (FDAzilla Blog).  This is a complicated question and has many complicated answers.  But the short answer is as specifically, comprehensively, quickly, and logically as possible for every single observation.  Attack each one with passion.  Explain to the FDA how the observations will be addressed, when, and how you’ll monitor it on an on-going basis.  Don’t be that company that gets repeat violations.
11. What have you learned from reading Form FDA 483 observations? (FDAzilla Blog). This post is an open thread for the fraternity of people who deal with 483s to share our collective tips on anything related to 483s.  There’s also 15 representative observations from selected 483s so you could see exactly what these look like.
12. Good and Bad response letters to Form FDA 483s (GxP Perspectives).  Carl Anderson reports from a session with 2 FDA employees on how to write a good 483 response.  (Hint: don’t say, “you cited us on a technicality)

Value-Added Tools

1. FDAzilla Pro Free – Free access to search sites, inspections, and the world’s largest database of FDA warning letters (we kept the older ones that the FDA has since dropped!).
2. Form FDA 483s Store. FDAzilla has thousands of FDA 483s that you can obtain instantly, anonymously, and economically.  This is really one of the only places where you can get access to this wide of a variety of 483s anywhere online, and it’s one of the largest collections available outside of the FDA.
3. 483s Subscription Service.  If you’re a heavy user of 483s, this service makes sense for you. You can get more 483s (7,000+ and growing 1,000 every year) than anywhere else.
4. GMP Regulatory Intelligence Email.  This is a super-helpful weekly surveillance email that covers enforcement actions, new developments, guidance, and papers – both related to the FDA and the EU. Saves a lot of people a lot of time trying to filter through a lot information.
5. FDA Inspector Profiles. Useful for preparing for your next FDA inspection, even if they are knocking on your front door right now.
6. Full-Text FDA 483s.  For advanced users who want to search the contents of thousands of 483’s.
7. Enforcement Analytics.  Slice and dice inspection data, warning letter information, inspectors, 483s. I don’t think there’s any other tools out there like this.

1. LinkedIn Group on Avoiding 483s.  Join other professionals in dialogue on the topic.  We can learn a lot from one another.