The US regulator published a Form 483 detailing six observations made during an inspection of Akorn’s facility in at 1222 W. Grand Ave, Decatur, Illinois in June this year.
The agency’s quality concerns related to documentation.
“There are no means of accounting for the total number of pages of forms used to document batch control and test results issued against the total number of pages used, discarded, or copied and the issuance of each control/test data form is not reconciled in Batch Records.”
Investigation
The Food and Drug Administration (FDA) inspectors also criticised Akorn’s failure to trace the root cause of “foreign matter” found in some drug batches.
“Foreign matter was identified as a known process-related defect, yet no specific root cause for the particulate was identified. And the most likely root cause of failure to identify the critical/major defects during 100% visual inspection was identified as human error.”
Akorn operates two manufacturing facilities in Decatur. The second facility on Wyckles Road is not mentioned in the Form 483.
The firm did not respond to a request for comment.