# FDA 483 - Jubilant Generics Limited - August 09, 2018

Source: https://www.keypedia.com/records/483/jubilant-generics-limited/14561873-2fd1-4ab1-b5ff-284e0338186b

> FDA 483 for Jubilant Generics Limited on August 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Generics Limited
- Inspection Date: 2018-08-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jubilant Generics Limited, a drug product manufacturer in Sikanderpur Bhainswal, India, was cited for significant quality system failures during an FDA inspection. Observations included inadequate investigation of material mix-ups and product complaints, failure to follow written procedures for in-process testing, and delayed submission of Field Alert Reports for distributed non-conforming products. These issues indicate a lack of robust quality control and timely regulatory reporting.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

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

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