FDA EIR - Lannett Company, Inc. - June 22, 2017

An FDA inspection of Lannett Company, Inc., a human drug manufacturer in Philadelphia, PA, was conducted from June 19-22, 2017. The inspection, carried out under Compliance Program Guidance Manual 7353.001 for Postmarketing Adverse Drug Experience (PADE) reporting, aimed to evaluate the company's system for processing and reporting adverse drug experiences. This was a follow-up to a 2012 inspection which cited failures in timely reporting of serious and unexpected adverse drug experiences to the FDA. The company had submitted an acceptable response and implemented corrective actions for the 2012 findings. During the current inspection, no Form FDA 483 (listing observations of objectionable conditions) was issued, indicating general compliance. A minor observation was noted regarding a Standard Operating Procedure (SOP RA-013) for reporting adverse drug experiences, which still described paper submission of Periodic Adverse Drug Experience Reports (PADERs) instead of the current electronic method. Lannett Company, Inc. committed to updating this SOP, and a revised version was provided shortly after the inspection, which will be reviewed in the next PADE inspection. The inspection confirmed that previous issues with late 15-day alert reports due to medical consultant review delays had been addressed through new contractual services. The company demonstrated adherence to its quality and safety data exchange agreements.