Form FDA 483s. If you’re part of the very small community of people who have “FDA 483s” in your vocabulary, we’ve created this web resource for you. Please see our list below of most helpful resources about FDA 483s.
Let’s start with why 483s matter: A Bad 483 Can Cost a Company Millions. We’ve heard too many stories of how one 483 was only the tip of the iceberg. This is why understanding the root issues inside 483s deserve your attention. You don’t want your CEO ever to say the words “FDA 483” or “manufacturing quality issues” on the national news.
Introduction to FDA 483s
- New to FDA 483s? Start here: FDA 483s (Wikipedia), the best 101 (and beyond) for understanding Form FDA 483s.
- FDA website ORA Reading Room. The FDA makes available Form FDA 483s that are “frequently requested” at this reading room. Though these Form FDA 483s only make up a small percentage of all their Form FDA 483s, it is helpful to check this page for updates (updated 1-2 times/month). We’ve noticed recently (as of late 2018) the FDA has increased their publishing rate and made more FDA 483s available, which is great for our industry.
- What’s the big deal about these Form FDA 483? Another great introductory post if you are new to the industry – “483s” is 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.
- Who can see FDA 483s, and where do I get them? Anyone can request 483s from the FDA through the Freedom of Information Act. But it can take anywhere from a few days to a few weeks (and occasionally, much longer than that) to receive the document. Keep in mind that your request is in itself public information, so people can find out what you’re poking around for. This is why we created the 483s store, for searchable, instantaneous, and anonymous access to thousands of 483s.
- Where Form FDA 483s begin: 3 Types of FDA Inspections. 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.
- A while back, we asked for the list of all 483-related Freedom of Information Act requests made to the FDA – this 483s FOIA Info PDF is the result. In 1 year, the FDA processed roughly 1,300+ 483-related FOIA requests. As you go through the list, you’ll see that it’s not just industry professionals who are analyzing these reports – you’ll also find investment firms, law firms, consulting firms, and even the media. When NBC News did a front-page story of tainted wipes, they asked us for the manufacturer’s 483s.
Let’s Get More Technical – Going Deeper with FDA 483s
- 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.
- How to Prepare for a GMP Inspection (at Smaller Companies). This is a great resource for small companies and for any team that is resource-constrained.
- 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. We break down the most important aspects of the beloved FDA 483.
- 5 Features to Look for in a Warning Letter, even if it’s not yours. Yes, there’s a more focused way to read these documents.
- 5 Features to Look for in an EIR. And, finally, you should look for specific aspects in a document called the Establish Inspection Reports (EIR) which the inspector uses to document every step of the inspection process. Not everyone agrees that these documents are worth the time, but many colleagues we have talked with like to read through the “play-by-play” of a particular inspection, giving them a more nuanced view of the inspector’s mentality and areas of focus.
- 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. There’s also 15 representative observations from selected 483s so you could see exactly what these look like.
- The New FDA GMP Inspection Model This was one of our most popular posts of 2017. FDA GMP has not changed much over the years; however, in 2018, the FDA went through a re-organization and is planning significant changes as to how they conduct GMP inspections.
- 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 for Avoiding FDA 483s
- Form FDA 483s Store. FDAzilla has thousands of FDA 483s that you can obtain instantly, anonymously, and economically. This is one of the only places online where you can get access to such a wide variety of 483s, and the largest collections available outside of the FDA.
- LinkedIn Group on Avoiding 483s. Join other professionals in dialogue on the topic. We can learn a lot from one another.
- Don’t just look at 483s, look at the inspectors who wrote them. Here’s how to inspect your inspector before your inspection.
- 483s Subscription Service. If you’re a heavy user of 483s, this service makes sense for you. You can get more 483s (10,000+) than anywhere else.
- 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 firehose of information.
- Enforcement Analytics. Slice and dice inspection data, warning letter information, inspectors, 483s searchable in full text. You can benchmark your company with your competitors, monitor/track suppliers/partners, do extensive research on key quality issues, and analyze your inspector’s history.
We are also increasingly asked about 483s for food companies. Here is more on FSMA and how to prepare for Food Manufacturing GMP inspections. A tremendous challenge for food companies is managing the vast number of suppliers and vendors across the globe – here are a few tips on how to monitor and benchmark your CMOs/suppliers.
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