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

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? 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.

Watch the webinar

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

Hosted by

Moderator/Presenter: Jon Speer

Founder, Greenlight Guru


About Greenlight Guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.

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