# FDA 483 - Suven Pharmaceuticals Limited - August 05, 2026

Source: https://www.keypedia.com/records/483/suven-pharmaceuticals-limited/bfcf14fc-793a-4afd-87c4-78a0f88f91dc

> FDA 483 for Suven Pharmaceuticals Limited on August 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suven Pharmaceuticals Limited
- Inspection Date: 2026-08-05
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Cohance Lifesciences Limited, an API and finished drug manufacturer in Sangareddy, India, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included unvalidated analytical methods, inadequate OOS investigations, deficient change control procedures, and poor material handling practices. These issues raise concerns about the quality and integrity of drug products distributed to the U.S. market.

## Related Documents

- [483 - 2018-02-15](https://www.keypedia.com/records/483/suven-pharmaceuticals-limited/4bc35ab4-88c6-46ee-9239-41e038fc07a5)

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)
- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/suven-pharmaceuticals-limited/c01306bf-33dc-4f28-a424-11cda764a0d5

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