Category: FSMA

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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How to Research the FDA with Keywords

The Easy Way to Research the FDA Using Keyword Search

The FDAzilla database contains information on every FDA inspected site since the year 2000. All of our 483s and warning letters — over 25,000 documents — are retyped, and keywords are tagged + categorized. In this video demonstration, we show you how to perform a keyword search of FDA warning letters in our system. To continue, either watch the video below or continue reading.

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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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FDA NASDA

NASDA and FDA Work Together to Implement the Produce Safety Rule

Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.

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