FDA 483 - Jubilant Cadista Pharmaceuticals, Inc. - January 15, 2025

Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD, a human drug manufacturer, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate control over master and batch production records, failure to make records readily available, improper quarantine of rejected in-process materials, and lack of systems and procedures to comply with DSCSA verification requirements. These issues indicate significant lapses in quality control and record-keeping practices.