Just weeks before Fresenius was allowed by a federal judge to walk away from its buyout of Akorn over quality concerns, FDA inspectors were in Akorn’s New Jersey plant for another inspection. What they found in the sterile drug facility were issues similar to those that led the German company to abandon the $4.3 billion deal.
Last week, the FDA posted the 22-page Form 483 that was issued to the Parsippany, New Jersey, plant following an inspection that began in late July and continued through August. The facility, which makes a number of sterile drugs, including eye products, lotions and jellies, was cited for nearly a dozen issues, some of which could lead to contamination, the documents says.
Among concerns, the FDA found plant employees fudging data, in one case rounding down test results to meet specifications for an impurity. The FDA found numerous cases of employees using “trial injections” ahead of official results. The out-of-spec results were then disqualified without sufficient reason. The inspectors noted that officials of the Akorn plant were told during a 2015 inspection that practice was unacceptable. Employees also found metal shavings in a lidocaine jelly but didn’t follow up to see if other lots were affected.
Germany’s Fresenius struck its deal to buy Akorn last year, touting the acquisition as a “strategically complementary combination” that would diversify its portfolio and expand its Fresenius Kabi sterile manufacturing capacity. With the deal, it was slated to add three U.S. manufacturing sites, plus another in India, and about 2,000 employees.
Earlier this year, however, the two companies disclosed that they were looking into whether Akorn violated FDA drug-development standards. The saga escalated when Fresenius abandoned the buyout in April. Akorn sued to try to force the deal on Fresenius, and the matter went to trial in July about the time that inspectors were in the New Jersey plant.
Last month, Delaware Vice Chancellor J. Travis Laster wrote that Fresenius fulfilled its contractual obligations in a merger agreement with Akorn and can legally exit the merger.
"Any second thoughts that Fresenius had about the Merger Agreement were justified by unexpected events at Akorn,” Laster wrote, citing data-integrity issues that came up at Akorn after the deal announcement.