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

Source: https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/24d515c5-b618-4f3c-8c04-0e61a2cbd79b

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

---

## Details

- Record Type: 483
- Company Name: Steril-Gene Life Sciences Private Ltd
- Inspection Date: 2022-11-17
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: During an inspection from November 17-25, 2022, the FDA observed Steril-Gene Life Sciences Private Ltd. in Puducherry, India, failing to follow and document written production and process control procedures. Specifically, operators performing aseptic filling interventions with lay-down vials did not document these actions, potentially compromising product integrity and sterility. This indicates a significant lapse in adherence to established manufacturing controls.

## Related Documents

- [483 - 2019-12-10](https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/8a3f06bd-b9dc-48ec-840b-bbda2031a3db)
- [483 - 2022-11-17](https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/fface9ec-3183-489b-8a76-665e2d937808)
- [483 - 2025-03-03](https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/8b28dde1-1544-42ca-a605-6375fb1c0909)
- [483 - 2026-08-12](https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/6000a84f-6e37-4d31-9ff9-c6ab6274fe06)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3