Akorn, Inc. – FDA 483, May 16, 2018

This FDA Form 483 documents significant deficiencies observed at Akorn, Inc., a sterile drug manufacturer in Decatur, IL, during inspections conducted from April 9-20, May 3, and May 7-16, 2018. The regulatory framework for these observations is Current Good Manufacturing Practice (CGMP). Key violations highlight a systemic failure in maintaining aseptic conditions and quality control. Investigators noted poor aseptic processing techniques, including improper material handling and operator conduct, some of which were recurring issues from previous inspections. The firm's environmental monitoring system was found insufficient, lacking proper sampling locations, scientific justification for monitoring frequencies, and timely identification of microbial flora. Furthermore, Akorn, Inc. failed to properly report manufacturing and control changes to the FDA in annual reports, such as changes in sterilization equipment and cessation of certain impurity testing. Cleaning and disinfection procedures for aseptic areas were not followed, leading to compromised sterility control. Significant data integrity issues were identified, including missing qualification documents, video records, testing data, and improper integration of analytical results. The company also failed to submit timely Field Alert Reports for product quality issues like pH trends and mold contamination. Finally, investigations into out-of-specification or out-of-trend results, particularly for personnel monitoring and laboratory events, were deemed inadequate, lacking thoroughness, documentation, and effectiveness checks. Akorn, Inc. is required to thoroughly investigate these observations, implement robust corrective and preventive actions, and respond to the FDA to demonstrate full compliance with CGMP regulations for sterile drug manufacturing.