Events
Duane Morris Special Counsel Michael Swit to Advise on "Successfully Responding to FDA 483s and Warning Letters"
July 10, 2012 | Audio Conference
Duane Morris special counsel Michael Swit will be presenting on the subject of "Successfully Responding to FDA 483s and Warning Letters" at an FX Conference audio conference on Tuesday, July 10, 2012.
While the FDA's enforcement powers range all the way up to criminal prosecutions of offending companies and corporate officials, the agency's prime compliance weapons are inspections and Warning Letters. Responding effectively and comprehensively to an FDA inspection or Warning Letter is essential if a company hopes to avoid stronger measures by FDA to ensure compliance. While the best way to successfully deal with an FDA inspection or warning letter is assiduous compliance with agency requirements, even the best companies will experience an inspection leading to a 483 and even a Warning Letter. The information in this presentation can help maximize the chances that an FDA inspection or Warning Letter does not lead to more severe consequences for your company.
This audio conference reviews the keys to successfully replying to 483s (inspection reports) and Warning Letters. The presentation also highlights recent changes in the FDA's policy governing those responses, and why it is so essential to be prepared in advance to deal with both inspections and Warning Letters. Mr. Swit will provide vital tips on how to address these prime FDA enforcement weapons, and will also highlight, using real examples, where some companies have fallen victim to poor responses and what they should have done differently.
For additional information, or to register, please visit the FX Conferences website.
