# FDA 483 - Jubilant Generics Limited - March 12, 2021

Source: https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/67003c16-ec1c-4768-8d71-d52ed40b5c21

> FDA 483 for Jubilant Generics Limited on March 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Generics Limited
- Inspection Date: 2021-03-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jubilant Generics Ltd. in Hardwar, India, received a Form 483 with seven observations related to significant deficiencies in manufacturing controls. Issues included inadequate equipment cleaning and maintenance, deficient cleaning validation, insufficient investigation of product defects, and failures in validating automated inspection equipment. Furthermore, the firm demonstrated poor data integrity practices, including inadequate data backups and control over computerized systems, alongside a quality control unit lacking sufficient authority and resources.

## Related Documents

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## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)
- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/jubilant-generics-limited/0e33a821-8bc0-4f36-9264-5a108f087380

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