# FDA 483 - Zydus Lifesciences Limited - April 25, 2025

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/4fa9d896-256e-483d-ab08-5db1c61aa4a8

> FDA 483 for Zydus Lifesciences Limited on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zydus Lifesciences Limited in Dabhasa, India, received a Form FDA 483 with six observations related to significant quality control and manufacturing deficiencies. Issues included inadequate complaint investigations, insanitary equipment, deficient GMP training, contamination risks from poor differential pressure control, failure to investigate product deviations, and insufficient water quality monitoring for API production. These findings indicate a serious lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2025-04-25](https://www.keypedia.com/records/483/zydus-lifesciences-limited/cdb37f39-766d-4cdb-afe7-1e9bab0f5980)

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/da6311ed-b3e1-4d8b-b794-8804a9eda435

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1