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.

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