FDA 483s Resource Center

FDA 483s.  If you’re part of the very small fraternity of people who have that phrase 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. 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.
7. 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.
8. 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.
9. Form FDA 483s listing, 2000 to present (FDAzilla).   FDAzilla updates this listing about once a quarter.  Do searches on locations, company names, years – a great way to get a specific, targeted list of 483s.  It’s the only database of FDA 483 listings that we’ve seen anywhere.
10. 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)

Presentations

1. How to Respond to a 483 (FDA Associate Director of Policy).  Get it straight from the FDA, right?  While it is from 2009, many of the key points remain as relevant today as they were back then.
2. How to Respond to a 483 (Paraxel Consulting).  26-page presentation filled with practical tips on how to respond to a Form FDA 483.
3. How to Respond to 483s (Biologics Consulting). Another presentation posted on FDAnews on how to respond to 483s, how the 15-day guideline impact the response, how to define CAPA, and some helpful examples.

Social Networking Resources

1. @FDA483s – a twitter stream curated by FDAzilla that is solely focused on… that’s right, you guessed it, avoiding 483s.
2. LinkedIn Group on Avoiding 483s.  Join other professionals in dialogue on the topic.  We can learn a lot from one another.

Value-Added Tools

1. Form FDA 483s Store.  (updated in late 2012!) FDAzilla has 1,000+ 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.
2. FDAzilla Report: Top Seven Strategies to Avoiding 483s.  FDAzilla analyzed 200+ 483s from 2009 and 2010 in the biotech/pharma sectors (representing 1,195 observations).  We talked to former FDA directors, front-line regulatory people, and other experts.  The result is this great report that identifies the 7 key areas of vulnerability.  Get this 31-page report (lots of graphs and charts), go through the assessment worksheet, and get your operations ready.  A must-have to prepare for 2011 and beyond.
3. Recent FDA 483s list. This is a list of 11,000+ FDA 483s from 2010 and first quarter 2011 – great for trending and seasonality analysis.
4. 2012 FDA Inspections and 483s list in excel format. Available for sale at the FDAzilla store. Yes, you’d get a list of all 40,000 inspections and see which ones resulted in a 483.

by Tony Chen