FDA 483 - Memorial Sloan Kettering Cancer Center - November 09, 2018

Memorial Sloan Kettering Cancer Center in New York, NY, underwent a GLP inspection that identified significant deficiencies. Observations included inadequate validation of analytical methods for determining test article concentrations, a study director's failure to address unforeseen circumstances impacting study integrity, and a quality assurance unit that did not accurately review final study reports against raw data. These findings indicate a lack of adherence to Good Laboratory Practices in their nonclinical laboratory studies.