3 FDA 483 Stories in the Last 3 Weeks – Gilead, Alexion, and Novartis

Now I know why we’ve been getting more calls/emails from financial institutions and hedge funds inquiring about FDA 483s – more and more investors are being introduced to the term during investor calls. While technical in nature, digging through a company’s history of 483s – especially when compared to competitor company’s profiles – can uncover potential vulnerabilities in their manufacturing systems. Continue reading

FDA 483s – THIS MAY SURPRISE YOU

Just like great football coaches watch film of opposing teams, we have to watch what the FDA is doing – learn their tendencies and habits. One of the best ways to do that is through our film – the FDA 483.

Need a quick refresh? Here’s a great list of 20 web-based (mostly free) resources on acing your next FDA inspection. This also includes a great 101 section to bring up to speed any new members of your team. Continue reading

20 Resources to Ace Your Next FDA Inspection

20resourcesFDA inspections.  If you find yourself googling FDA inspector names, if you see your boss’s new Porsche parked in the parking lot with a license plate that says, “Zero 483s” (true story), then part of your job includes preparing your facility to be ready at any second for an FDA inspection.

This post is for you.  Here are our top 20 resources and FAQs for you:

FDA inspections 101

  1. What does the FDA inspect?  The FDA inspects all “manufacturers or processors” of FDA-regulated products – this includes these kind of manufacturers: vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, and animal processors.  The objective of these inspections are to ensure that they comply with all relevant regulations.
  2. What are the 3 types of FDA inspections. If you’re new at this, it’s important to understand the 3 basic reasons an FDA inspector is conducting the inspection. Continue reading