Respond Effectively to FDA ... or else! - Jan 29, 2008

Here's another Warning Letter issued by FDA for an inadequate response to a Form FDA 483, List of Inspectional Observations. This one was issued to Noven Pharmaceuticals, Inc. on Jan 4 - right after the holidays.

It is critical that we not only develop good, effective, science-based responses to an FDA inspection, but then implement what you said you would do. ESPECIALLY if you receive a Warning Letter - because you know the FDA will be back to reinspect after issuing a Warning Letter.

Read the letter issued to Noven. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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