FDA 483 - Immunomedics, Inc. - March 10, 2020

Immunomedics, Inc. in Morris Plains, NJ, a drug substance intermediate manufacturer, was inspected by the FDA from March 2-10, 2020. The inspection revealed significant deficiencies across quality control, facility maintenance, equipment qualification, and data integrity, indicating a systemic lack of adherence to established procedures and controls. These issues pose a high risk to the microbiological control and overall quality of the drug substance intermediate.