FDA EIR - Leonard G. Gomella, M.D. - September 13, 2019

An FDA inspection of Dr. Leonard G. Gomella, a clinical investigator at Thomas Jefferson University Hospital in Philadelphia, PA, occurred from September 3 to September 13, 2019. This routine bioresearch monitoring inspection, conducted under compliance program 7348.811 for clinical and sponsor investigators, was the third for Dr. Gomella.

The inspection concluded without an FDA Form 483, meaning no formal observations were issued. A primary discussion item involved a lapse in Institutional Review Board (IRB) continuing review and approval for one clinical study (Protocol (b)(4)) during two periods: December 2014 to February 2016, and February 2017 to November 2018. This highlighted the need for continuous oversight of human subject research protocols. Management stated that a centralized regulatory organization, established in 2016, now uses automated reports to prevent future expiration lapses.

Furthermore, a single instance of investigational product temperature excursion during shipping was identified. The sponsor promptly resolved this by directing the destruction of the compromised shipment and arranging for a replacement. No other significant issues or refusals were documented, and the inspection generally found protocols were followed, informed consent documents were properly executed, and facilities were deemed adequate.