# FDA 483 - Steril-Gene Life Sciences Private Ltd - March 03, 2025

Source: https://www.globalkeysolutions.net/records/483/steril-gene-life-sciences-private-ltd/8b28dde1-1544-42ca-a605-6375fb1c0909

> FDA 483 for Steril-Gene Life Sciences Private Ltd on March 03, 2025. 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: 2025-03-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Steril-Gene Life Sciences Private Ltd, a human drug manufacturer in Puducherry, India, was cited for significant deficiencies across three observations. The inspection revealed inadequate laboratory controls for sterility testing, including method suitability and control processes, which could lead to false-negative results. Additionally, the firm lacked established and followed written procedures for in-process visual inspections, particularly concerning personnel training and qualification for detecting foreign material in drug products. Finally, procedures to prevent microbiological contamination of sterile drug products were not followed, with issues in aseptic personnel qualification and environmental monitoring.

## Related Documents

- [483 - 2019-12-10](https://www.globalkeysolutions.net/records/483/steril-gene-life-sciences-private-ltd/98cb4747-526c-4ea1-841b-98df21777d32)
- [483 - 2022-11-17](https://www.globalkeysolutions.net/records/483/steril-gene-life-sciences-private-ltd/fface9ec-3183-489b-8a76-665e2d937808)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

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