The US Food and Drug Administration’s letter to Akorn cited violations of current good manufacturing practice (cGMP) regulations, including procedures related to monitoring the plants environment and personnel. Additionally, the agency noted foreign fibers and contaminants on gloves that were supposed to be sterile.
The warning letter came after Akorn’s response to the FDA’s Form 483 issued in November was deemed inadequate by the agency.
Akorn’s Decatur plant manufactures sterile filled liquid injectables, sterile lyophilized injectables, ophthalmic bottle sterile filled liquid, prescription, over the counter, and controlled drug substances.
Neither the warning letter nor the previous Form 483 were the first instances of FDA action regarding Akorn’s facility.
In 2016, the FDA filed a Form 483 to the same plant after observations of quality control. The agency found traces of foreign matter in some of the plant’s drug batches and the company was unable to find the root cause of the matter. Later in 2016, the FDA re-inspected the plant and issued a positive observation.
Moreover, Akorn’s CEO resigned in December 2018 and the company has not yet announced a replacement for the former CEO, Raj Rai.
Following this most recent letter, Akorn’s shares dropped by 8.9%.
The company expects to continue production at the plant.