FDA 483 - Immunomedics, Inc.

An FDA inspection of Immunomedics, Inc.'s Drug Substance Intermediate Manufacturing Facility in Morris Plains, NJ, revealed significant quality control and data integrity deficiencies. Observations included a failure to investigate a data integrity breach, inadequate retesting procedures, and a lack of control over raw materials and inventory. The facility also exhibited issues with environmental monitoring, design, and critical quality system processes like deviation handling, CAPA implementation, and cleaning validation, indicating a broad breakdown in GMP compliance.