# FDA 483 - Zydus Lifesciences Limited - June 18, 2025

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/47a83472-6d58-4c2a-be9c-ef2902950f7a

> FDA 483 for Zydus Lifesciences Limited on June 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2025-06-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zydus Lifesciences Limited in Matoda, Gujarat, India, a sterile drug product manufacturer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the Quality Unit's procedures for investigating invalid laboratory results and a lack of adequate validation for aseptic process simulation studies, raising concerns about product sterility assurance.

## Related Documents

- [483 - 2024-03-27](https://www.keypedia.com/records/483/zydus-lifesciences-limited/9082a7d8-9d0d-46f0-bbdd-3911d03fa272)
- [483 - 2025-11-13](https://www.keypedia.com/records/483/zydus-lifesciences-limited/ba22390b-1935-47f4-a8c5-f737a8de8633)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

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

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