Category Archives: FDA

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.

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

How Does the Government Shutdown Impact FDA Inspections?

Half Open, Half Closed

The government is still shut down, though the FDA is still about half-open.  The question is: which half?

The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading

FDAzilla mentioned on front-page WSJ story

 

FDAzilla was mentioned in a front-page story today in the Wall Street Journal.  The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.

Current and potential investors of your company may actually be reading your FDA 483.

Read the whole article here>> Continue reading

The Most Famous QA/RA Blogger Just Revealed His Identity

QAPharm_1

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world.

For years, we’ve been following The QA Pharm Blog. Writen with an equal dose of deep industry expertise, refreshing transparency/voice, and wit, we’ve all wondered – who is this masked man? Continue reading

Everything you’ve ever wanted to know about how FDA 483s are written

We receive a lot of questions, especially from our international colleagues, about how FDA 483s are actually written – the whole “lifecycle”, if you will.  Based on manuals and other FDA resources that are publicly available, we answer your 10 most frequently asked questions in this area. Especially if you are new to FDA 483s, this is for you.  For the seasoned among you, this is a good review. Continue reading

Avoiding FDA 483s Strategy #7: Get serious about employee training

In another significant slip, inspectors found that Zorro Technology had not given employees any training in cGMPs (or at least couldn’t prove that they had).

Today is our last strategy for avoiding cGMP 483s – make sure QA employees are adequately educated, trained and supervised. Again, this may seem obvious, but in a cutthroat environment where R&D gets the money and QA the budget cuts, it doesn’t always happen. Continue reading