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

The FDA issued a Form 483 to Immunomedics, Inc. following an inspection conducted from June 14, 2018, to August 1, 2018. The inspection, which focused on the company as a sponsor of clinical trials, identified several significant observations related to clinical study conduct and regulatory compliance. Key issues included a failure to consistently inform all participating investigators about new observations, such as the discovery of particulate matter in an investigational product lot. The FDA also noted inadequate monitoring of studies, specifically the inability to locate numerous Interim Monitoring Visit Reports and Site Initiation Visit Reports, and a delay in finalizing many Interim Monitoring Visit Reports beyond the 60-day timeframe. Furthermore, the labeling for investigational new drugs did not bear the required cautionary statement, instead using a less specific phrase. A critical observation concerned the use of an unvalidated computer program for recording clinical trial data, which also lacked an audit trail, compromising the reliability and trustworthiness of electronic records. Immunomedics, Inc. is required to address these observations to ensure their clinical trials are conducted in accordance with federal regulations and established protocols, safeguarding data integrity and patient safety.