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Form 483 Watch: Medical Devicemaker Inspections in the News

Published: April 2011 |  Pages: 292 |  Price:  $377  | ISBN:  978-1-60004-238-6  | Table of Contents

What hotspots in your operation could prompt an FDA inspector to issue you a Form 483?

You can wait until the inspectors arrive to find out. Or, you can get ahead of the curve by learning exactly what’s triggering citations in other companies and fixing your similar vulnerabilities before the inspector arrives.

Start now … with access to the actual Form 483s being issued to companies just like yours.

New from FDAnews
Form 483 Watch: Medical Devicemaker Inspections in the News

Form 483s provide the most detailed record available of what happened during an inspection and what problems triggered citations.

Now, in one convenient source, Form 483 Watch: Medical Devicemaker Inspections in the News provides an authoritative reference collection of the most newsworthy Form 483s issued recently to device manufacturers.

In addition to the actual inspection findings, this FDAnews report includes insights and analysis on what the inspections mean regarding everything from quality assurance to your relationships with service providers.

Buy now for a one-stop, fully searchable reference to 48 important FDA inspection 483s issued during the past 18 months, including:

  • Summaries of the inspections making headlines and analysis of why they’re important to your own compliance strategy
  • Intelligence on the specific problems prompting inspectors to issue citations
  • Actual Form 483s that provide a complete record of the inspection findings so you can benchmark — and FDA-proof — your own situation.
When it comes to helping you defuse potential “triggers,” this report helps you minimize uncertainty and worry about FDA inspections. Don’t wait another moment to put this powerful risk management tool to work!

Buy Now!
Form 483 Watch: Medical Devicemaker Inspections in the News is offered by FDAnews in searchable PDF format for $377.

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PDF Version

ISBN: 978-1-60004-238-6
PDF will be available to download after your purchase is complete.