# FDA 483 - Sai Life Sciences Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sai-life-sciences-limited/e13941d1-e603-40e6-8a8b-3c173c775504

> FDA 483 for Sai Life Sciences Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sai Life Sciences Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sai Life Sciences Ltd., Unit II, a testing laboratory in Hyderabad, Telangana, revealed significant deficiencies in their LIMS implementation and qualification. The firm failed to assure that API and in-process materials conformed to specifications due to inadequate verification of instrument functionality and unverified calculations within the LIMS system. This raises concerns about data integrity and product quality for products released to the US market.

## Related Officers

- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.globalkeysolutions.net/companies/sai-life-sciences-limited/6a4eee18-c1a6-4bc3-8ba0-014f87b57c2d

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