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.
FDA 483 Articles & Resources:
- The New FDA GMP Inspection Model. A primer on the different types of inspections and what to expect from each.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FDA 483s. A website we’ve created that’s focused solely on avoiding and responding to Form FDA 483s.
- 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.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
About the Author
Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.