Dealing with the FDA is never easy, but two of the most disconcerting times for medical device companies are when an FDA investigator issues a List of Observations (the FDA483) at the conclusion of an inspection, and when you receive a letter from the FDA by certified mail that has "Warning Letter" written at the top.
Now what do you do? The 483 never says you must reply either verbally or in writing, but the warning letter states that you must respond to FDA concerns in writing within 15 days. How do you respond to the 483 and/or the warning letter? Does it make a difference in how you make your response? Who reads your response and what effect does a good response have on the FDA's next regulatory step? Join us as device consultant and former FDA supervisor Alan Schwartz provides the answers.
How to Respond to FDA 483s and Warning Letters is presented by Alan Schwartz, Executive Vice President, of mdi Consultants, Inc. For more information on this audio conference, please visit our site www.fxconferences.com
