This is the second warning letter the specialty drug manufacturer has received from the US Food and Drug Administration (FDA) regarding its facility.
The FDA sent the company a warning letter in January 2019 regarding its Decatur, Illinois facility not long after the agency issued a Form 483 in November of that year regarding the inspection that took place at the Somerset facility between July 23 and August 30.
The Form 483 for the Somerset facility noted 11 observations, including the finding that batches of Akorn’s ophthalmic solution, that had failed stability testing, entered the US market. Additional observations included issues with laboratory controls lacking appropriate test produces to assure drug products meet the appropriate standards.
In a statement addressing the warning letter, Akorn President and CEO Douglas Boothe said Akorn has launched a companywide action plan to improve its operations and, quality systems, and will also focus on transparency, he said.
Boothe added that the company will work to resolve all issues raised by the agency’s letter and expects to continue production at the Somerset facility.
Akorn’s shares have fallen 70.5% over the past 12 months.