# FDA 483 - Cohance Lifesciences Limited - October 31, 2025

Source: https://www.globalkeysolutions.net/records/483/cohance-lifesciences-limited/5d6a0246-5a18-4275-b42c-36e338ead866

> FDA 483 for Cohance Lifesciences Limited on October 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2025-10-31
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Cohance Lifesciences Ltd (DBA Chromo Labs India Private Ltd) in Hyderabad, India, a biopharmaceutical analytical facility, was cited for significant data integrity issues during an FDA inspection. The firm was observed deleting analytical instrument run data and having incomplete audit trails for method validation parameters. These findings indicate serious concerns regarding the reliability and integrity of their analytical data.

## Related Documents

- [WARNING_LETTER - 2025-08-12](https://www.globalkeysolutions.net/records/warning_letter/cohance-lifesciences-limited/82d97f9c-aa45-433f-bd29-66a8a005fcff)

## Related Officers

- [Melkamu Getie Kebtie](https://www.globalkeysolutions.net/people/melkamu-getie-kebtie/e7c26e5f-2f7f-46ad-83bc-09006f3cdc26)

Company: https://www.globalkeysolutions.net/companies/cohance-lifesciences-limited/8d5664bf-2d4e-44f3-abcc-c98c49d62e8a

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321