Tag: inspections

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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FDA 483s Resource Center

What’s the Big Deal with Form FDA 483s?

Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them.
Today, we cover the basics. Some of you pros out there know this stuff all too well…

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