7 Resources for Avoiding Form FDA 483s

As we’ve written extensively about the infamous Form FDA 483 here at FDAzilla, we’ve decided to make it easier for you.  Here, we’ve created a centralized list of the 7 best resources to go from Joe to Pro on understanding Form FDA 483s.

Form FDA 483 Articles & Resources

    1. Where Form FDA 483s begin: 3 Types of FDA Inspections.  A primer on the 3 different types of inspections and what to expect from each.
    2. 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.
    3. 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.
    4. 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.
    5. What have you learned from reading Form FDA 483 observations? 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.  We also reproduced representative 15 observations from selected 483s so you could see exactly what these look like.
    6. FDA 483s A website we’ve created that’s focused solely on avoiding and responding to Form FDA 483s.
    7. Avoiding Form FDA 483s LinkedIn Group – A group we’ve created that’s focused solely on 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.

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

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6 thoughts on “7 Resources for Avoiding Form FDA 483s

  1. James Hamilton

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

    Reply
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