An Akorn sterile injectables plant in Illinois is in hot water with the FDA again, but this time it may be a problem for Fresenius Kabi, which is buying the generics manufacturer in a $4.3 billion deal.
According to a recently posted FDA Form 483, the agency found new issues with Akorn’s sterile manufacturing during an inspection of the Decatur plant in April.
That came just months after Akorn announced that an FDA reinspection of the plant last year had cleared it over the 11 observations, many tied to filling lines, that turned up in a June 2016 visit.
RELATED: Akorn U.S. sterile plant passes FDA reinspection
The April inspection includes only three observations, but they hark back to earlier problems. In fact the inspector said that the plant has been unable to validate or complete a third of the media fills on one line in a room that had been converted for aseptic filling.
In one case, the inspector reported that the company released products even after it was pointed out to Akorn’s VP of domestic sterile products quality assurance that particles that might contaminate injectables appeared to be shedding from a conveyor belt used for staging washed vials. The inspector noted that the plant has produced 88 lots on that line since it was was set up in that configuration. The Form 483 also noted that equipment was not designed so it could be easily cleaned.
RELATED: Fresenius pulls off sterile injectables double whammy, snags Akorn as well as Merck KGaA's biosimilars business
But that may all be up to Fresenius to address. In April, about the time the plant was being inspected, the German drugmaker agreed to buy Akorn as part of a two-deal play to expand its sterile manufacturing capacity. It got three U.S. plants and one in India in the Akorn deal, which is slated to close in early 2018.
Sterile injectables accounted for about 35% of Akorn's $1.1 billion in sales last year, but analysts also liked that Fresenius was additionally acquiring some new segments like ophthalmics and topical solutions, which might be less vulnerable to the generics pricing pressure that has made life difficult for generics producers in the last few years.
On the same day, Fresenius said it would buy the biosimilars portfolio of Germany-based Merck KGaA for €170 million upfront and up to €500 million in milestone payments, about $729.2 million total. The deal with Merck puts Fresenius in a position to capture a piece of the billions of dollars in sales that will be up for grabs as some of the world’s best-selling injectable drugs go off patent in the next few years. Manufacturing of biosimilars will continue at Merck's two plants in Switzerland as part of that deal.
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