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How To Avoid and Respond to FDA 483's and Warning Letters

View the Free On-Demand Webinar

How long has it been since your last FDA inspection?

You know FDA is technically mandated to inspect any company with class II or class III products every two years (and inspections have been on the rise particularly for foreign / outside the US firms).

If FDA called tomorrow to announce their plans to visit your facility next week would you be prepared?

Even the most prepared companies still often find themselves receiving 483 observations.

Then you must act swiftly and effectively to avoid that observation escalating to a warning letter.

But what exactly do you do?

How do you respond to FDA 483 observations and/or warning letters?

greenlight.guru founder and VP QA/RA, Jon Speer, has been through his fair share of FDA inspections over the course of his 17+ year career in the medical device industry and has helped many of companies respond to 483 observations and warning letters along the way.

In this free, 60 minutes webinar, Jon will be sharing his most effective tips on how to avoid 483’s and warning letters in the first place along with a step-by-step guide to responding the them if you do happen to receive either.

SPECIFICALLY you'll learn:

  • What you should be doing to always be prepared for an FDA inspection

  • How to help prep your team before an FDA inspection

  • The top 7 reasons FDA issued medical device companies 483 observations and warning letters in FY2015

  • Tips you can implement today to mitigate your risk of getting 483’s and warning letters

  • What you need to do before responding to a 483 to minimize the damage (and avoid the common pitfalls)

  • Best practices for responding to FDA 483 and warning letter (including a free response template)

  • The differences in responding to a 483 observation vs. a warning letter

  • What to expect from FDA after submitting your response




About greenlight guru

Greenlight Guru's beautifully simple Quality Management Software helps medical device companies bring devices to market faster while reducing risk and ensuring compliance.



Founder & VP QA/RA
Greenlight Guru