inspections

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What’s the big deal with Form FDA 483s?

by Tony Chen Okay, let’s settle this once and for all.  This week, we will be writing 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 [...]

By | 2017-05-29T10:35:28+00:00 February 28th, 2011|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|