Tony Chen

Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.

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.

Who Can See 483s

Who Can See Form FDA 483s, and Where Do I Get Them?

Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are …

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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 our database.  As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month).  Yes it’s true:  arguably, the …

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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 – leading large teams, collaborating with customers, and expertly scaling businesses. Feel free to connect with him at [email protected] or on LinkedIn. Read the press release here. I will step down from …

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Week of Feb 4th 2018 | FDA Sent These Warning Letters for Pharma Companies

FDA Sent These 5 Warning Letters for Pharma Companies | September 2017

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use. From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent):