# FDA 483 - Unexo Life Sciences Private Limited - May 14, 2024

Source: https://www.globalkeysolutions.net/records/483/unexo-life-sciences-private-limited/96eac3cd-91e4-4221-aa88-2d6fee3e654f

> FDA 483 for Unexo Life Sciences Private Limited on May 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unexo Life Sciences Private Limited
- Inspection Date: 2024-05-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This 483 report for Unexo Life Sciences, Private Limited, details severe data integrity deficiencies, inadequate quality control unit oversight, and a lack of thorough investigations into adverse events. The inspection revealed significant issues with record-keeping, method validation, computer system controls, equipment maintenance, and process validation, indicating a systemic failure to ensure the quality and safety of drug products. These findings highlight a critical breakdown in cGMP compliance across multiple operational areas.

## Related Documents

- [WARNING_LETTER - 2024-05-14](https://www.globalkeysolutions.net/records/warning_letter/unexo-life-sciences-private-limited/0bdc6157-bfd2-4bad-b0ac-c9ecd5aa968e)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/unexo-life-sciences-private-limited/0a2a6fc8-1ef3-46dc-a2ca-f4eb344630e3

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