Specialty generic pharmaceutical company Akorn (AKRX) - Get Report said Tuesday that it received a warning letter from the U.S. Food & Drug Administration regarding an inspection of the company's Somerset, New Jersey facility in July and August 2018.
The Lake Forest, Illinois-based company said in a statement that it will respond to the FDA letter within the required 15 working days.
"Akorn is committed to resolving the warning letter in a comprehensive and effective manner," Douglas Boothe, president and CEO, said in the statement. "Earlier this year, Akorn launched a companywide action plan to improve the timing and effectiveness of our operations, quality systems and compliance enhancement initiatives, with an emphasis on transparency and quality. We believe the execution of this action plan, which has already begun to yield tangible results, will strengthen and further standardize our quality systems across the entire Akorn network."
The company said "it has full confidence in the quality of the products manufactured at the Somerset facility and expects to continue production at the plant."
In February, the FDA raised concerns about its manufacturing plant in Amityville, New York, that included a lack of records on the maintenance and cleaning of equipment, according to news accounts.
In April 2018, Akorn shares sank after Germany's Fresenius Medical Care (FSNUY) dropped its planned $5 billion takeover of the drugmaker after a probe into possible data breaches by the U.S. Food & Drug Administration.
Shares of Akorn were down 3.8% to $4.55 in premarket trading.