# Cohance Lifesciences Limited – FDA 483, Sep 4, 2026

Source: https://www.keypedia.com/records/483/cohance-lifesciences-limited/c0837c7f-9a21-40dc-b5e6-5e651483ef5d

> FDA 483 for Cohance Lifesciences Limited on September 04, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cohance Lifesciences Limited
- Inspection Date: 2026-09-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cohance Lifesciences Limited, a finished drug product manufacturer in Rangareddy District, India, was cited for significant deficiencies during an FDA inspection. The inspection revealed failures in thoroughly investigating out-of-specification results, inadequate procedures for preventing objectionable microorganisms, and a quality unit that did not fully follow its written responsibilities. Additionally, the firm lacked appropriate controls over computerized systems, indicating serious data integrity concerns.

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/cohance-lifesciences-limited/d37d278e-85f7-4fb5-b9d9-8d19b9a8ccea

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