FDA 483 - Jens Hillengass, M.D., Ph.D. - February 09, 2024

An FDA inspection of Roswell Park Comprehensive Cancer Center in Buffalo, NY, identified significant deficiencies in the conduct of clinical investigations. The principal investigator failed to adhere to investigational plans and protocol requirements, resulting in subjects being dosed despite toxicity and enrollment of a subject with exclusion criteria. Additionally, serious adverse events were not reported to the sponsor in a timely manner.