Akorn reports positive results from a recent FDA cGMP compliance inspection of the Decatur, IL manufacturing facility. This inspection also served as a preapproval inspection (PAI) for Akorn’s new lyophilization operation.
As a result of this inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial, and lyophilization production filling suites in Decatur.
According to Akorn, the agency found satisfactory resolution of past cGMP issues. The FDA District of Chicago office also confirmed they had reported to the FDA Center for Drug Evaluation and Research that the firm’s responses to the subject inspection appear to be acceptable.