Author: Tony Chen

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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Best Job I Ever Had

“The Best Job I Ever Had”

“As FDAzilla continues to grow, we believe we must do our part – locally and globally – to do good by doing well.” Tony Chen (one of our co-founders) shares this unique story of who we really are at FDAzilla.

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483 Cost

A Bad 483 Could Cost a Company Millions

I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.

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Is AI Coming to FDA Inspection Management?

Is AI Coming to FDA Inspection Management?

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20,000 FDA Warning Letters

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in

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Introducing FDAzilla’s New CEO

I’m thrilled to announce that Michael de la Torre is FDAzilla’s new CEO, effective October 19, 2017.  He comes to us after an already-amazing run in executive roles at several companies

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