Jubilant Pharmova LimitedDecember 13, 2022

FDA 483 - Jubilant Pharmova Limited - December 13, 2022

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Record Details

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.

Company: Jubilant Pharmova Limited
Inspection Date: December 13, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Yvins Dezan
Dipesh K. Shah

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ID · b331bff2-fd60-42e5-b28b-2e7e4b0c6056