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It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:
There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive. But now there’s a new, better way to acquire 483s. Introducing the 483s Resource Center from FDAnews. For the first time ever, you can get actual copies of 483s in as little time as just a few minutes, as well as other products that can tell you more about how to use 483s to ensure your inspections go as well as possible. Products from the 483s Resource Center couldn’t be easier or more convenient to order. Simply click on the chart below to learn more about them. We’re sure that you’ll find one that will be the most effective for your needs, timeline – and budget.
Books & Reports About 483s
Responding to FDA 483s: Strategies for Successfully Obtaining Closeout
Learn the best practices for managing the post-inspection process so you don’t get callbacks
from the FDA. Responding to FDA 483s is a plain-English step-by-step guide that goes beyond boilerplate advice and digs into specifics that help you fashion a top-quality response to your next Form 483. Learn More
Form 483 Watch: Drugmaker Inspections in the News
Now, in one convenient source, Form 483 Watch: Drugmaker Inspections in the News provides an authoritative
reference collection of the most newsworthy Form 483s issued recently to pharma manufacturers. Learn More
Form 483 Watch: Medical Devicemaker Inspections in the News
Now, in one convenient source, Form 483 Watch: Medical Devicemakers Inspections in the News provides an authoritative reference collection of the most newsworthy Form 483s issued recently to device manufacturers. Learn More
Form 483 Watch: Focus on API Manufacturers
Imagine having access to recent FDA inspection reports on API manufacturers — especially if they’re your competitors — whenever you need them. Well, now you can. In fact, you can have immediate access to 50 recent 483s, compiled in one, easy-to-access volume, with this collection from FDAnews. Learn More
Conference Audio CDs About 483s
Responding to 483s and Warning Letters: Strategies for High-Stakes Communications
Anatomy of a Medical Device Inspection: From EIRs to 483s to Warning Letters
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