Location: Somerset, New Jersey
The warning letter for an Akorn manufacturing facility in Somerset, New Jersey, is not exceptional in and of itself, but more because it illustrates just how far a company can fall as a result of poor manufacturing.
At the time the warning was issued, management was working to forestall a default by negotiating a standstill agreement with lenders, an agreement it received and that continues in place.
That Akorn hangs on by the skin of its financial teeth is a far cry from three years ago when Germany’s Fresenius struck a $4.3 billion buyout deal for the sterile injectables maker. But the billions in value were gone in a flash after Fresenius got tipped off that Akorn violated FDA drug-development standards. Fresenius pulled the plug on the deal.
Fresenius successfully argued during litigation that the uncovered problems were at the core of Akorn's franchise and would take years to resolve. The two warning letters Akorn received in 2019 are testament to that observation.