# FDA 483 - Jubilant Pharmova Limited - December 13, 2022

Source: https://www.globalkeysolutions.net/records/483/jubilant-pharmova-limited/b331bff2-fd60-42e5-b28b-2e7e4b0c6056

> FDA 483 for Jubilant Pharmova Limited on December 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Pharmova Limited
- Inspection Date: 2022-12-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

- [483 - 2017-10-27](https://www.globalkeysolutions.net/records/483/jubilant-pharmova-limited/71db58c0-1550-4ae2-83c7-b46215e1b6b1)
- [483 - 2018-12-18](https://www.globalkeysolutions.net/records/483/jubilant-pharmova-limited/c7ad4d03-1496-4d1e-90ef-c5557ca4b219)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/jubilant-pharmova-limited/a01c2832-8b6e-44ba-a73e-dd7649feb936

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1