# FDA 483 - Zydus Lifesciences Limited - May 05, 2026

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/1c906068-dd53-464c-a476-7db7bb0cd4d0

> FDA 483 for Zydus Lifesciences Limited on May 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2026-05-05
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Zydus Lifesciences Limited in Ahmedabad, India, a sterile drug manufacturer, revealed significant deficiencies across its operations. The firm failed to adequately investigate discrepancies, maintain aseptic processing areas, and ensure proper environmental controls. These issues, including insufficient validation of sterilization processes and lack of electronic data review, indicate a serious risk to the sterility and quality of drug products intended for the U.S. market.

## Related Documents

- [483 - 2026-05-05](https://www.keypedia.com/records/483/zydus-lifesciences-limited/9c966bde-77c1-43ce-8b42-080b2c50808e)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/1c40f7df-1e2e-48cb-b768-ad55e472ad64

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