# FDA 483 - Sun Pharmaceutical Industries, Inc. - April 18, 2025

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-inc/6d67dfb6-ce41-4aa1-b4d4-11718b3709b1

> FDA 483 for Sun Pharmaceutical Industries, Inc. on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries, Inc.
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: New England District Office
- Summary: The FDA inspection of Sun Pharmaceutical Industries, Inc. revealed significant deficiencies across multiple areas, particularly concerning quality control and facility maintenance. The firm failed to thoroughly investigate numerous complaints, equipment failures, and out-of-specification results, impacting both sterile and non-sterile drug products. Additionally, issues were identified with unclean equipment, unmaintained facilities, inadequate water systems, and poor control over materials and labeling.

## Related Documents

- [483 - 2019-12-23](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-inc/71f35efa-bfd5-4df3-a2cc-2a2c5673cd35)

## Related Officers

- [Armen H. Youssoufian](https://www.keypedia.com/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-inc/1a56d6cb-288c-42d5-9558-e4301ffebc65

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144