# ZYDUS LIFESCIENCES LIMITED – FDA 483, Oct 13, 2026

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/98ef8893-f996-4d37-82aa-5e453dbeca9a

> FDA 483 for ZYDUS LIFESCIENCES LIMITED on October 13, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZYDUS LIFESCIENCES LIMITED
- Inspection Date: 2026-10-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Zydus Lifesciences Limited, a non-sterile drug manufacturer in Sanand, India, received an FDA Form 483 citing multiple significant deficiencies. Observations included under-reported microbial growth in laboratory records and inadequate investigations for product discrepancies and out-of-trend results. The firm also lacked systems for DSCSA compliance, failed to perform performance verification on FTIR instruments, and continued reduced testing of materials despite specification failures.

## Related Documents

- [483 - 2022-08-05](https://www.keypedia.com/records/483/zydus-lifesciences-limited/526e9778-49d9-4bc9-b141-4277fae2da3f) — date: August 5, 2022
- [483 - 2019-05-03](https://www.keypedia.com/records/483/zydus-lifesciences-limited/051be815-7257-4aef-b52e-f6f008747283) — date: May 3, 2019

## Related Officers

- [Martin M. Kimani](https://www.keypedia.com/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)
- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/aa40e2a7-c250-4524-b05f-6ca311474c5c

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