FDA 483 - Jubilant Generics Limited - August 09, 2018

Jubilant Generics Limited, a drug product manufacturer in Sikanderpur Bhainswal, India, was cited for significant quality system failures during an FDA inspection. Observations included inadequate investigation of material mix-ups and product complaints, failure to follow written procedures for in-process testing, and delayed submission of Field Alert Reports for distributed non-conforming products. These issues indicate a lack of robust quality control and timely regulatory reporting.