# FDA 483 - Sun Pharmaceutical Industries Ltd - May 13, 2024

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/e1d88195-7400-4402-a0e8-5259842fbbb6

> FDA 483 for Sun Pharmaceutical Industries Ltd on May 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd
- Inspection Date: 2024-05-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sun Pharmaceuticals Industries Limited in Dahej, India, received a Form 483 for significant deficiencies in its API manufacturing operations. The inspection revealed issues with equipment maintenance, HVAC system operation, and pest control, all contributing to contamination risks. Additionally, the firm failed to adequately test impurity reference standards and lacked detailed sampling procedures for active pharmaceutical ingredients.

## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Haitao Li](https://www.keypedia.com/people/haitao-li/62ce7565-d80f-4570-962a-8e6bfc88d0c1)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-ltd/771469b2-c59c-423e-9ae7-6ce113d3928a

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