The Ultimate Resource for Avoiding Form FDA 483s

/, Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices/The Ultimate Resource for Avoiding Form FDA 483s

The Ultimate Resource for Avoiding Form FDA 483s

As we’ve written extensively about the infamous FDA 483 here at FDAzilla, we’ve decided to make it easier for you. Here, we’ve created a centralized list of the best resources to go from Joe to Pro on understanding FDA 483s.

Click here to get free
483 data on any company you choose.

FDA 483 Articles & Resources:

    1. The New FDA GMP Inspection Model. A primer on the different types of inspections and what to expect from each.
    2. A Bad 483 Could Cost a Company Millions. We spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.
    3. What’s the big deal about these Form FDA 483?  “483s” are the industry shorthand for “Form FDA 483s”, the official inspection report that documents FDA inspector observations of manufacturing facilities. While a response from the inspected company is not required, wise companies respond quickly and comprehensively.
    4. Who can see Form FDA 483s, and where do I get them? Anyone can request 483s from the FDA through FOIA, though it takes more time than you might expect. Remember, too, that your request itself is public information, so people can find out what you’re poking around for.
    5. 6 Features to Look for in FDA 483s. A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, this post covers the questions you need to ask.
    6. How to Respond to a Form FDA 483. The short answer is as comprehensively, quickly, and logically as possible for every single observation. Attack each one with passion. Explain to the FDA what you’re going to do to address the issues, how you’re doing to do it, when you’re going to do it, and how you know you’ve done it. Don’t be that company that gets repeat violations.
    7. How the FDA and the 483 Have Changed? We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483.
    8. FDA 483s. A website we’ve created that’s focused solely on avoiding and responding to Form FDA 483s.
    9. Avoiding Form FDA 483s LinkedIn Group. A group we’ve created that’s exclusive to topics re: avoiding and responding to 483s. There’s only so many of us who live and breath this stuff, and we can learn a lot from one another.

Like this & want more?
Sign up to get free weekly content updates
designed to make your job easier

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at

About the Author

Paul Brooks

Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.


  1. James Hamilton March 15, 2011 at 3:07 pm - Reply

    Great resource for understanding and responding to FDA 483’s and how to avoid them in the first place.

  2. […] to join us on this important topic.  In the meantime, don’t forget to check out our list of 10 resources for avoiding 483s.  Also check out our new research on 200+ 483s on the top seven strategies to to avoid […]

  3. […] In our opinion, the best way to avoid a consent decree is to avoid a warning letter.  The best way to avoid a warning letter.  The best way to avoid a warning letter is to avoid a 483.  The best way to avoid 483s is to read our 10 best resources for avoiding FDA 483s. […]

  4. […] plans to “move away” from it’s healthcare division.  For more on 483s, go to our Top 10 List of Resources to understand and avoid 483s.  For the most recent listing of 483s, go to our 483s List […]

  5. […] What are you seeing?  Are 483s getting more attention at your organization?  Here are 10 of our favorite resources on FDA 483s. […]

  6. […] 10 Resources for Avoiding 483s>> […]

Leave A Comment