# FDA 483 - Cohance Lifesciences Limited - March 07, 2025

Source: https://www.keypedia.com/records/483/cohance-lifesciences-limited/4731918d-2864-4c8f-a283-e51712a0a2e4

> FDA 483 for Cohance Lifesciences Limited on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cohance Lifesciences Limited, an Active Pharmaceutical Ingredient Manufacturer in Hyderabad, India, was inspected by the FDA from March 3-7, 2025. The inspection revealed significant deficiencies across quality control, including inadequate review of laboratory incidents and OOS investigations, unvalidated analytical methods, deficient equipment qualification, and failures in quality unit responsibilities. These issues indicate a lack of robust quality systems for ensuring product quality and data integrity.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.keypedia.com/companies/cohance-lifesciences-limited/8e48a668-3018-4c94-b846-2cdd61205a18

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8