Resources

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 […]

We just added another 150 FDA 483s into the FDAzilla 483s store, bringing the total to just shy of 3,500 FDA 483s. Search by inspector or company any time. Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.

The FDA ended 2013 with 39,774 inspections – a 5-year low. It’s the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522). We’ve updated our FDA inspections/483s database through early January 2014. It’s hard to say what is driving the big drop this year (8% drop from last […]

It has been quite a year for FDA 483s and Warning Letters.  Here are the top 5 stories for 2013: The number of Inspections and 483s came down again for the 2nd year in a row. Is this a long-term trend?  Hard to say.  Here’s the data. No 483s and inspections for about 2 weeks […]

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 […]