The letter, dated Jan. 4, cites violations observed between April 9 and May 16 during an inspection of Akorn’s Decatur facility. The violations of current good manufacturing practice regulations include inadequate facility design, the potential for contamination, and poor environmental and personnel monitoring, according to the FDA letter.
Akorn’s stock fell 9% to $3.58 between the close of market Tuesday and Wednesday morning.
The company has 15 working days to respond to the FDA letter in writing, telling the agency what it has done since the inspection to correct each violation and prevent them from recurring, according to the letter.
“The company has full confidence in the quality of the products manufactured at the Decatur facility and expects to continue production at the plant,” Akorn said in a statement today.