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RECENT POSTS

How to Respond to 483s

How to Respond to FDA 483s

What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts that we dive into in this post.

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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 WARNING LETTERS

FDA FORM 483s