US FDA publishes Akorn Pharmaceuticals’ Form 483

US FDA publishes Akorn Pharmaceuticals' Form 483

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.”InvestigationThe Food and Drug Administration 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 particulat…

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