# FDA 483 - Sai Life Sciences Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sai-life-sciences-limited/fda654f2-48ca-48c4-9520-8a90580007ba

> 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 Limited in Bidar, India, revealed significant deficiencies in their quality system. The firm failed to adequately investigate unexplained discrepancies, including the proper identification of foreign particles in manufacturing materials and the complete documentation of maintenance activities. These issues indicate a lack of robust quality control and record-keeping practices.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/sai-life-sciences-limited/726cbe1d-0e58-4b7f-ac62-b511c905ac02)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/sai-life-sciences-limited/607f1442-4dd8-43d5-bd9a-80b913df696c

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