# FDA 483 - Zydus Lifesciences Limited - November 13, 2025

Source: https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/ba22390b-1935-47f4-a8c5-f737a8de8633

> FDA 483 for Zydus Lifesciences Limited on November 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2025-11-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zydus Lifesciences Limited in Matoda, Gujarat, India, a finished drug product manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate validation of sterilization processes for sterile drug products and a failure to conduct adequate investigations into microbiological data deviations in aseptic processing areas. These issues indicate a lack of control over critical aspects of sterile manufacturing and quality system oversight.

## Related Documents

- [483 - 2024-03-27](https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/9082a7d8-9d0d-46f0-bbdd-3911d03fa272)
- [483 - 2025-06-18](https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/47a83472-6d58-4c2a-be9c-ef2902950f7a)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/zydus-lifesciences-limited/4904f62e-dd42-4ea9-b381-cb6e5d44558d

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