Resources

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 […]

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 […]

Ranbaxy stock took a 30% hit today following an import alert issued by the FDA. The alert was reportedly issued based on serious cGMP issues at the Mohali plant from September and December 2012 483s.  Ranbaxy’s other two plants in India were already barred from importing to the U.S., this third plant in India was […]

We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details. Some observations from a brief glance into the data: There are 225,000+ inspections […]

By popular demand, we’re excited to announce that we have recently more than doubled the size of our 483 library. After painstakenly obtaining, organizing, renaming, and categorizing these documents, we now have 2,300+ 483s and counting in our library available in PDF format for immediate purchase and download. Better yet, you can now search by […]

Today’s post is written by guest blogger Greg Hattoy. Greg is a regulatory compliance specialist and insightful industry writer at his blog,greghattoy.com. Greg takes a distinct approach to regulatory issues and shares his innovative vision for the direction of the pharmaceutical industry As a regulatory professional, lately it has becoming glaringly apparent that the only […]

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 […]

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, […]

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 […]

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 […]