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.
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…
New FDA 483s Video
If your job involves preparing for FDA inspections, watch this video and tell us what you think! Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.