PRESS RELEASE: New Data Provides FDA-Regulated Industries Unprecedented Insights Into FDA Inspection Trends and Enforcement Actions

CHICAGO, IL – May 14, 2015

FDA Inspections at a glanceToday, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity.  For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.

“Smart data has arrived onto FDA inspections.  We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla. Continue reading

FAQ: “Why Do You Sell FDA 483s? Aren’t they free?”

Good question, I’m glad you asked!

It’s true that the FDA releases FDA 483s on their ORA FOIA Reading Room. However, these represent only the most frequently requested 483s. In fact, if you look over the years, there are probably close to 100,000 FDA 483s sitting somewhere on an FDA server.  They release only a few a week.

FDAzilla requests many additional FDA 483s from the FDA.  Our database is getting close to 5,000 FDA 483s, one of the largest in existence.  We then utilize custom software that we have developed over the years to tag each FDA 483 by inspector, inspection, site, inspection date, and other relevant data elements.  This tagging enables you to search 483s by any of these data elements in the FDAzilla 483 store.

Data integrity and the FDA

Data Integrity: The Whole Story

Last week, Barbara Unger shared about the new regulatory expectations regarding GMP Regulatory Intelligence.  Indeed, we have heard that FDA inspectors have started asking people about what processes we have in place to monitor new regulations, guidelines, and developments.  In part, this is why we now offer the GMP Regulatory Intelligence newsletter.

This week, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market cap has been lost because of this one issue.  The crazy part is this – it’s not even close to being a new issue.  As you’ll see, the data integrity story began at least 15 years ago. Continue reading

New Question FDA Inspectors May Ask You at Your Next Inspection

ARE YOU READY-I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence.  It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines.  Here’s what she had to say: Continue reading

THE BIG PICTURE- 5 KEY TAKE-AWAYS FROM

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading