Seminar October 30, 2008

Responding to 483s and Warning Letters: Strategies for High-Stakes Communications

Event Detail
Cathy L. Burgess
October 30, 2008
Cathy Burgess was a speaker during this audio conference sponsored by FDA NewsFact: GE Healthcare recently received its third warning letter in a year and a half, this one alleging inadequate CAPA procedures for software packages ... Ranbaxy Laboratories, which has been under scrutiny and received warning letters, now has more than 35 products banned from entering the U.S. ... and the list goes on!

Fines, recalls, injunctions — how companies respond to an FDA Form 483 should not be taken lightly. From timing to format to content, each step taken in analyzing the 483 and preparing a response can mean the difference between getting a product successfully to market and denial of access to the market.

With the stakes this high, why would anyone risk offering an unsatisfactory response? Yet it happens all the time ... poorly planned responses often result in warning letters stating the information was inadequate, incomplete, poorly written or unsatisfactory — and can lead to even bigger penalties down the road.

This program covered how to assess the FDA's concerns and respond appropriately to avoid making common mistakes that result in warning letters.  The program analyzed the language from actual 483 and warning letter responses and discussed why the response given was good or unsatisfactory. The following topics were covered during the presentation

    • How to analyze a 483 or warning letter — even when it isn't obvious what the FDA is expecting
    • 10 essential dos and don'ts when writing your response to the FDA
    • The proper structure of a response — the FDA is less likely to miss the good things you're doing if you provide the format they want to see
    • Five common mistakes to avoid — now is not the time to wave a red flag
    • The significance of making and keeping FDA commitments — showing good faith can go a long way
    • Why developing timelines for corrective action plans is vital — it's not just what you do but when you do it
    • The importance of supporting documentation — if you can't prove it, you didn't do it
Meet The Speakers
Media Contacts
Nicholas Clarke
Senior Communications Manager
Phone: 212.210.1222
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