FDA 483 - Jubilant Pharmova Limited - December 18, 2018

Jubilant Generics Limited in Nanjangud, India, received a Form 483 with 12 observations following an inspection from December 10-18, 2018. The observations highlight significant deficiencies across multiple areas, including inadequate investigations into impurities, deficient analytical method validation, poor cleaning validation and equipment maintenance, and inadequate control over starting materials and laboratory data. These issues indicate a lack of robust quality control and manufacturing practices for active pharmaceutical ingredients (APIs).