FDA 483 - Memorial Sloan Kettering Cancer Center - September 20, 2022

An FDA inspection of Memorial Sloan Kettering Cancer Center's Non-Clinical Laboratory in New York, NY, revealed several deficiencies. Observations included failures to conduct nonclinical laboratory studies in accordance with protocols, improper identification of specimens, and inadequate maintenance of the master schedule sheet by the quality assurance unit. These issues indicate a lack of adherence to established procedures and documentation requirements for nonclinical studies.