# FDA 483 - Zydus Lifesciences Limited - September 05, 2025

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/14d393f5-c922-4e58-8b77-8195044f86dc

> FDA 483 for Zydus Lifesciences Limited on September 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2025-09-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zydus Lifesciences Limited, a sterile drug product manufacturer in Vadodara, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into microbial contamination and out-of-specification/out-of-trend results, deficient cleaning and disinfection procedures in aseptic processing areas, and a lack of controls to prevent environmental monitoring data manipulation. The firm also failed to adequately monitor environmental conditions in aseptic processing areas.

## Related Documents

- [483 - 2018-08-28](https://www.keypedia.com/records/483/zydus-lifesciences-limited/81cdb49b-259d-42de-8ac8-2a5a2a21d6d2)
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- [483 - 2025-08-25](https://www.keypedia.com/records/483/zydus-lifesciences-limited/47d2a205-2a54-4738-8c1a-bf7e92782212)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/b4ab6750-9275-47bd-a575-c425b82b300d

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