FDA 483 - Akorn Operating Company LLC - August 30, 2018

Akorn, Inc. received an FDA Form 483 following an inspection, citing significant deficiencies in quality control and manufacturing processes. The observations highlight failures in thoroughly investigating unexplained discrepancies, out-of-specification results, and stability failures, often attributing issues to personnel error without scientific justification. The report also details inadequate data integrity controls, including the widespread practice of unreviewed "trial injections" and lack of proper electronic record review.