Category Archives: biopharma

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

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

4 Trends About GMP Inspection Readiness and FDA Data Intelligence

I hope you read our recent post about the backstory of our company, FDAzilla. We’ve come a long way in 5 years. As we plan for the next 5 years, we’ve been preparing for our annual executive team meeting in April.  As such, our team researches and synthesizes the most important trends to which we must respond and adapt. Continue reading

3 Questions with Barbara Unger

Yesterday was Part I. Today, we get to hear a little more from Barb on her background.Barbara Unger

What publicly available information do you depend on for your job? How do you use that information?

I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information quickly. The ICH and PIC/S websites also publish their guidance in an organized way. Compliance actions taken by FDA and EMA are also published. I also read publications in the major newspapers and several blogs. Sometimes the best information can come from an unanticipated source. Continue reading

What FDA enforcement trends do you see in your industry?

Barbara UngerThis week, I got a chance to ask our new editor-in-chief of GMP Regulatory Intelligence a few questions. Her responses were so thorough and insightful that we decided to publish her responses in as a series. Today is part I, where we asked her: “What FDA enforcement trends do you see in your industry?” Continue reading

New FDA 483 Subscription Service Available

Get all the 483s you need. FDAzilla now offers an FDA 483s SUBSCRIPTION SERVICE where you can access all of our 483s any time you want throughout the calendar year. We have one of the most comprehensive libraries of 483s, with 3,500+ 483s that is updated quarterly (We anticipate bringing in at least 1,000 more in the next 12 months).

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Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.