# FDA 483 - Zydus Lifesciences Limited - March 20, 2023

Source: https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/34c162be-2a18-433d-9ead-459d81785ae8

> FDA 483 for Zydus Lifesciences Limited on March 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2023-03-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zydus Lifescience Limited, a drug product manufacturer in Ahmadabad, India, was cited for three significant issues during an FDA inspection. Observations included inadequate cleaning and maintenance of manufacturing equipment leading to potential cross-contamination, a failure to thoroughly review unexplained discrepancies in laboratory testing, and a lack of adequate oversight on the use of qualified reference standards and analytical method validations. These issues indicate serious deficiencies in quality control and manufacturing practices.

## Related Officers

- [Pratik S. Upadhyay, DDC Investigator](https://www.globalkeysolutions.net/people/pratik-s-upadhyay-ddc-investigator/6772e2cf-8ea9-4b67-8a8a-2361a389e557)

Company: https://www.globalkeysolutions.net/companies/zydus-lifesciences-limited/1715db78-d88c-4e31-a5e0-cf81fb62411b

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