FDA 483 - Immunomedics, Inc. - January 23, 2003

Immunomedics, Inc., a biologics manufacturer in Morris Plains, NJ, was cited for multiple deficiencies during an FDA inspection. Key issues included incomplete investigations into failures and complaints, inadequate documentation of QA reviews, and incomplete employee training records. Additionally, the firm failed to validate a critical test method and shipping procedures, establish specifications for chromatography column limits, and consistently follow water system monitoring SOPs.