- The Food and Drug Administration has hit Akorn with a lengthy Form 483 critiquing the company's quality control unit at a Somerset, New Jersey facility, inspected by the regulator over three weeks in July and August.
- This isn't a new problem for the generics company; it's the tenth Form 483 issued to Akorn by the FDA since September 2010. Eight of those reports were directed at another facility in Decatur, Illinois.
- Akorn's shares are down over 40% since the end of September, when a judge supported Fresenius Kabi's decision to pull out of a proposed takeover deal for Akorn.
On Oct. 1, a Delaware judge ruled Fresenius Kabi's decision to withdraw from a takeover deal to buy Akorn for $4.3 billion was valid. This change of heart followed investigations into Akorn's data quality, data integrity and product development that raised some serious concerns, and resulted in Akorn's stock tumbling downward. The investigation came after an anonymous tip over the breaches at Akorn.
One red flag involved Mark Silverberg, Akorn's former head of quality function, approving a response to a complete response letter on an abbreviated new drug application (ANDA) that would result in the submission of false data. The ANDA was later withdrawn.
According to court documents, the FDA's data integrity requirements mean drugmakers must "prove the origin, transmission, and content of the company's data and that data is what it is purported to be." The document also describes data violations as "particularly serious because they 'break trust' between the offending company and the FDA."
While the fresh inspection report doesn't call out data integrity requirements by name, it raises many related issues including failure to review unexplained discrepancies and batch failures as well as a lack of controls over computer systems.
In one instance, an investigation was initiated following observation of metal shavings in a batch of lidocaine hydrochloride jelly. While two batches were rejected, Akorn judged two other batches made during the same manufacturing campaign to be unaffected without proper documentation or investigation, the FDA's report states.