# FDA 483 - Sun Pharmaceutical Industries Ltd. - November 08, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/1b76acf1-0cc6-46a8-bd3d-14c1d7bed7a9

> FDA 483 for Sun Pharmaceutical Industries Ltd. on November 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2019-11-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sun Pharmaceutical Industries Ltd. in Baruch, Gujarat, India, received a Form 483 for significant deficiencies in their API manufacturing operations. Observations included inadequate written procedures for testing leading to potential data integrity issues, insufficient investigation and documentation of Out-of-Specification results, and incomplete investigations of quality-related complaints. These issues indicate a lack of robust quality control and data management practices.

## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-ltd/a3b25a73-6014-41fa-802f-abd1fe33382c

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