FDA EIR - Lannett Company, Inc. - January 25, 2019

An FDA inspection of Lannett Company, Inc.'s Philadelphia, PA facility occurred from January 23-25, 2019. This comprehensive current Good Manufacturing Practice (cGMP) inspection, conducted under frameworks for Drug Manufacturing Inspections and Drug Quality Reporting, assessed the firm's operations for solid oral dosage forms and oral solutions. The inspection found the facility in the process of decommissioning its drug manufacturing activities, with production transferring to a sister site in Indiana. The Philadelphia site is currently maintaining stability studies and will transition to solely research and development by 2021. Although no FDA Form 483 (Inspectional Observations) was issued, a significant discussion point concerned the **lack of effectiveness reviews for corrective and preventative actions (CAPAs)** over the previous two years, with some CAPAs closed without the required checks. Additionally, the firm lacked several adverse event Drug Quality Reporting System (DQRS) reports, prompting immediate investigations. Corrections from a previous 2016 inspection regarding incomplete complaint investigations and cleaning validation were verified as addressed. Required actions for Lannett primarily involve implementing robust CAPA effectiveness monitoring and thoroughly investigating all product quality reports.