# FDA 483 - Steril-Gene Life Sciences Private Ltd - November 17, 2022

Source: https://www.globalkeysolutions.net/records/483/steril-gene-life-sciences-private-ltd/fface9ec-3183-489b-8a76-665e2d937808

> FDA 483 for Steril-Gene Life Sciences Private Ltd on November 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steril-Gene Life Sciences Private Ltd
- Inspection Date: 2022-11-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Steril-Gene Life Sciences Private Ltd. in Puducherry, India, the FDA observed significant deviations in aseptic filling operations. Operators failed to follow written production and process control procedures and did not document critical interventions, such as righting fallen vials, which could compromise product integrity and sterility.

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## Related Officers

- [Dennis Cantellops Paite](https://www.globalkeysolutions.net/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.globalkeysolutions.net/companies/steril-gene-life-sciences-private-ltd/0885ef5e-2fd7-42c0-927d-7cf3c2410eec

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