# FDA 483 - Zydus Lifesciences Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/9935734a-1d7a-4677-a942-a12e82cb31f6

> FDA 483 for Zydus Lifesciences Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zydus Lifesciences Limited, a drug substance manufacturer in Changodar, India, revealed significant deficiencies across multiple quality systems. Observations included inadequate process validation for API intermediates, insufficient investigations into out-of-specification results, and unverified or unvalidated test methods. Additionally, the firm's change control system, batch production records, and laboratory control records were found to be incomplete or inadequate, indicating a lack of robust quality oversight.

## Related Documents

- [WARNING_LETTER - 2024-04-23](https://www.globalkeysolutions.net/records/warning_letter/zydus-lifesciences-limited/6bfb1bde-7e8a-4667-a6ff-70da8c31c3e7)

## Related Officers

- [Kalsoq A. Habook](https://www.globalkeysolutions.net/people/kalsoq-a-habook/61985dd6-28f4-4dc1-a3c1-194771856838)
- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.globalkeysolutions.net/companies/zydus-lifesciences-limited/ad3c6024-a4cc-403f-86ab-fe86668ef0bc

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