Compliance with FDA Requirements: What Are Executives Thinking or Not Thinking??

Recently, Novartis took a “$120m charge to improve a US manufacturing plant and recall drugs after the FDA sent it a 483”. For those uninitiated in FDA-speak, form 483 is used by the FDA to document and communicate concerns discovered during factory inspections.

In this case, Novartis recalled bottles of Excedrin, Bufferin, Gas-X and NoDoz which “may have included mixed up pills,” which according to the FDA “may have accidentally been packaged with powerful prescription painkillers made at the same facility”. In 2010, according to the FDA, this facility had not rectified 165 of the 587 complaints against it.

Is this an isolated incident or does this occur often?

In 2008, the FDA issued 483 forms 4,987 times. Along with other enforcement events, such as seizures, injunctions, and convictions, these events resulted in fines or restitutions totaling $846,591,080:

Moreover, FDA statistics show that enforcement events have gone up:

There are at least three major consequences from the incident to Novartis: The company lost money. The reputation of the company suffered. The public lost faith in the company. Admittedly, the FDA might be getting better organized, inspecting more, etc (which could explain for the increased enforcement events), but here are my questions – What were the manufacturing executives in charge thinking? And, what should organizations be doing to address the growing number of enforcement events that are occurring?

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