4 Trends on The Rise of the FDA 483

4 Trends on The Rise of the FDA 483

By | 2016-07-11T09:49:27+00:00 January 14th, 2013|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form 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.

    1. More interest from hedge funds.  That’s right – we are actually getting contacted more and more frequently by hedge funds, investment banks, and others in the investment banking community asking about 483s.  After the third one called me, I inquired about their interest.  Indeed, manufacturing quality and the risks of a warning letter/consent decree now factor into the investment risk profile of major pharmaceutical companies.  I’m not saying that 483s can turn a “buy” into a “hold,” but follow the money.  And the money says, 483s – their frequency as well as their substance – are now one of the factors that investment professionals plug into their system to evaluate investment risk.

 

    1. More interest from law firms.  I’m also surprised by the frequency that we are contacted by law firms asking specific, detailed, and informed questions about 483s.  They are more tight-lipped about their intentions, but my guess is they are doing either a risk analysis for their big manufacturing clients or they are prowling for class-action lawsuits.

 

    1. More interest from reporters.  By far, this has been the biggest surprise to me.  There are now several high-profile news stories that actually quote or significantly cite FDA 483 reports (I’ll provide this list in another post). These once-obscure, highly-technical documents called FDA 483s are growing in prominence and impact.   What’s interesting is that some reporters are quite sophisticated in their knowledge of 483s, and understand the FDA process and warning letters, etc as well as an industry insider.

 

    1. More interest from industry.  To be honest, I’m not sure if this is true. We have definitely seen a huge uptick of interest from industry people – regulatory affairs directors/managers, quality assurance professionals, manufacturing supervisors, and corporate compliance execs.  This may just be specific to FDAzilla, though I also believe that these professionals are now getting smarter with the web.  Several times in the last few months, we’ve seen people purchase all the FDA 483s issued by a specific inspector. We’re guessing that an FDA inspector shows up at your door, and you get someone to google ’em.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

 

What are you seeing?  Are 483s getting more attention at your organization?  Here are 10 of our favorite resources on FDA 483s.

3 Comments

  1. […] Now with over 1,000+ FDA 483s, the FDAzilla 483s store gives you anonymous access to PDF format FDA 483s in seconds. Visit the FDA 483s store>>  You can now search by inspector name, too. We’ve honestly been dumbfounded at the increasing number of calls we get from some surprising groups, asking us more detailed and more intelligent questions around about FDA 483s.  Here’s 4 groups that are looking into these FDA 483s more than you might expect>> […]

  2. […] parties such as investors, law firms and the press are interested in warning letters and 483s. Click here to learn more about some of the rising trends related to the FDA […]

  3. Tony February 18, 2013 at 2:07 pm - Reply

    update: just saw this. 483s are now making into CEO quarterly remarks to investors:
    http://www.outsourcing-pharma.com/Contract-Manufacturing/Hospira-s-Manufacturing-Woes-Continue-with-US-Device-Plant-483

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