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

Immunomedics, Inc. in Morris Plains, NJ, was subject to an FDA BioResearch Monitoring inspection from June 14 to August 1, 2018. This inspection, carried out under the regulatory framework for sponsors and contract research organizations, revealed several critical deficiencies in the company's clinical trial conduct.

Primary violations included a failure to notify all participating investigators about new findings, specifically particulate matter identified in an investigational product lot. The company also exhibited inadequate study monitoring, as evidenced by lost Site Initiation Visit Reports for five clinical sites, missing Interim Monitoring Visit Reports, and numerous reports not finalized within the stipulated 60-day period. Additionally, Immunomedics failed to complete required analyses on 17 study subjects, with five samples untraceable, impeding a definitive safety evaluation of the investigational drug.

Further issues comprised the investigational drug label not displaying the mandatory "Caution: New Drug—Limited by Federal (U.S.) Law to investigational use" statement. Crucially, an electronic database utilized for clinical data was unvalidated and lacked an audit trail, falling short of 21 CFR Part 11 requirements for electronic records. General discussions also highlighted the absence of a study-specific monitoring plan, a standard operating procedure for medical waivers, and thorough training records for clinical research associates.

The company's Chief Medical Officer received a Form FDA-483 outlining these observations and committed to submitting a written response within 15 business days, detailing corrective and preventative measures.