Resources

Over the years, we’ve written quite extensively about avoiding 483s. Here’s a summary of some of the most timeless advice and perspective. While the technologies change and the areas of FDA emphasis change quite a bit, the basics of inspections don’t change. Here’s 7 basic strategies for avoiding FDA 483s. Like the saying goes, sometimes […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 11/5/13 Contour Healer Virginia Beach VA United States 12/4/13 Contract Pharmacal Corporation Hauppauge NY United States 4/16/14 Convatec Inc. Skillman NJ United States 7/30/13 Cook Inc. Spencer IN United […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 4/3/14 American Contract Systems, Inc Waunakee WI United States 2/24/14 American Medical Systems, Inc. Minnetonka MN United States 2/29/12 American National Red Cross Columbus OH United States 1/24/14 American […]

Based on our latest data, we’re seeing a major downturn in FDA inspections this year. Possibly 25%. Check out the chart above. As you can see, the lagging in late 2013 makes sense with the sequestration (started October 1), but look at the green 2014 trend line – what do you think is going on? Here […]

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 […]