FDA 483 - Jubilant Cadista Pharmaceuticals, Inc. - February 28, 2020

An FDA inspection of Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD, revealed significant deficiencies in manufacturing practices, complaint handling, and regulatory reporting. Observations included inadequate procedures to prevent microbial contamination during packaging, failure to properly investigate product complaints, and delayed submission of field alert reports for serious product defects. These issues suggest a lack of control over critical quality processes.