Immunomedics, Inc. – FDA 483, Aug 1, 2018

Immunomedics, Inc. in Morris Plains, NJ, was inspected regarding a clinical study and received a Form 483 with four observations. Deficiencies included failure to inform investigators of product issues, inadequate study monitoring, incorrect investigational drug labeling, and unvalidated electronic records lacking audit trails. These issues indicate significant concerns with clinical trial oversight and data integrity.