Author: Barbara W. Unger

Changes in the FDA

How the FDA and the 483 Have Changed

We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483.

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FDA 483s Resource Center

6 Features to Look for in FDA 483s

A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.

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