FDA 483 - Scott Bloom, M.D. - February 16, 2018

Scott Bloom, M.D., a clinical investigator in New York, NY, was cited for significant deficiencies during an FDA inspection. The firm failed to conduct an investigation in accordance with its investigational plan, specifically regarding the dispensing and weighing of investigational product. Additionally, investigational drug disposition records were found to be inadequate, lacking complete information and containing discrepancies.