Building a Culture of Quality and Compliance: Are 483's Just Part of Doing Business?

Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))

  • Contamination during the manufacture of serum injectables?
  • Failure to measure or account for endotoxins?  
  • Failure to respond to adverse patient reactions?  
  • Presence of vermin and unsanitary conditions at the facility?

One might think they came from reports of the disgraceful conditions that FDA found in NECC’s compounding facility, but, no, they come from pharma’s own cGMP regulated facilities and were pointed out in recent FDA 483’s and Inspection Reports.

Pharma’s diligent and altruistic manufacturing and quality control professionals do all they can (when properly supported and encouraged) to prevent things like this from happening.  It’s a difficult job, at best.

But can this heavily regulated industry afford to cast the first stone when it comes to NECC’s current predicament? Didn’t the troubled compounder make the same kinds of mistakes that some of the biggest pharma and generics companies in the world have made (and continue to make), in responding to the same challenging market forces?

If Toyota’s CEO considers product quality at the top of a short list of issues, why is it that Quality Control is still considered “too granular” for many pharma CEO’s?  Recall, if you will, the J&J executive report that came out last year.


Or the fact that a prominent CMO’s CEO last year was widely quoted in the press as saying that receiving a 483 is just a normal part of doing business.  

Our latest cover story touched on some of these issues, which were also grist for an editor’s rant.  But what do you think, and what will be needed to transform pharma’s culture into one of consistent quality and safety?  Please write me at ashanley@putman.net  if you can.


Agnes Shanley