The FDA processed roughly 12,000 FOIA requests in the last 12 months. That’s right, 12,000. 1,000 every month. About one every ten minutes that the office is open. Continue reading
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
This 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
Based on our latest data, we’re seeing a major downturn in FDA inspections this year. Continue reading
It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013: Continue reading
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 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.
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
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
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
Abbott Nutrition was cited a few years ago for failing to exclude pests from processing areas. This was the plant’s 31st citation related to warehouse beetle infestations since 2007.
This one may seem obvious, but since it comes up repeatedly in the 483 batch from 2012, let’s say it again. If the FDA cited you in the past, letting the same conditions stay in place is asking for trouble. Big trouble. Continue reading
Meridian Medical Technologies was cited when inspectors saw a something “which appeared rust-like…on the bottom of the stainless steel plate located across the top of the window in Room [b] in the class [b] area where EpiPen NGA is manufactured.”
Ventilation problems. Rust on the walls. Drips in the pipes. Not only are these ugly, they’re going to get you cited. You may know this, and your quality team too, but sometimes small mechanical or functional problems get ignored or minimized. Continue reading