FDA 483 - Jubilant Pharmova Limited - December 13, 2022

Jubilant Pharmova Limited, an API manufacturer in Nanjangud, India, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies in the firm's quality unit responsibilities, investigation processes, personnel training, equipment cleaning and maintenance, facility sanitation, computer system controls, and batch record practices. Repeat observations highlight persistent issues with equipment cleaning and facility maintenance.