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

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/cdb37f39-766d-4cdb-afe7-1e9bab0f5980

> 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 Inspections and Investigations
- Summary: Zydus Lifesciences Limited in Dabhasa, India, received a Form 483 following an inspection of its API manufacturing facility, revealing significant deficiencies. Issues included inadequate complaint investigations, insanitary equipment, widespread GMP training failures, and insufficient contamination control measures. The firm also failed to document deviations and properly monitor water quality for sterile drug product APIs.

## Related Documents

- [483 - 2025-04-25](https://www.keypedia.com/records/483/zydus-lifesciences-limited/4fa9d896-256e-483d-ab08-5db1c61aa4a8)

## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8