Category Archives: Form FDA 483

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.

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

Data Integrity: The Whole Story

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

Now, 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 capital 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

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

How the FDA has changed, How the 483 has changed, & how we should use 483s to get smarter

Barbara UngerBarbara Unger, new editor-in-chief of GMP Regulatory Intelligence, has been providing some great insights on this blog. Last week, she shared her perspective about key FDA enforcement trends. Yesterday, she gave us some insights on her previous roles.

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Is the FDA ORA reading room bookmarked on your browser? Get GMP Regulatory Intelligence

 

  • Is part of your job to prep your company for FDA inspections?
  • Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers?
  • Is the FDA ORA reading room bookmarked on your browser?

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.