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We’ve talked to a lot of people who are seeing increased attention on FDA 483s.
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10 FDA 483 News Stories
Here’s 10 recent stories that have hit our radar related to FDA 483s: Continue reading
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
Funding Cutbacks at FDA: A Sequester Primer
At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Continue reading
The State of the FDA—February 2013
FDA is the only federal agency that touches the lives of every American several times every day. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. 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
FDA conducted 40,000+ inspections in 2012
Actually, 41,129 to be exact. That’s almost 5 inspections per hour for the entire year of 2012. Based on new data that we obtained from the FDA, here are some other interesting statistics:
- 2 inspections in Bangladesh
- 1 inspection in Botswana
- 223 inspections in China Continue reading
20 Resources to Ace Your Next FDA Inspection
FDA 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
- 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.
- 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
4 Trends on The Rise of the FDA 483
by Tony Chen
I believe that FDA 483s are becoming increasingly important in our industry. Now that we’ve been in this particular space for almost 4 years, I’ve noticed some key trends. Continue reading
New FDA 483s Video
If your job involves preparing for FDA inspections, watch this video and tell us what you think!