# SUN PHARMACEUTICAL INDUSTRIES INC – FDA 483, Jul 24, 2026

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-inc/341c46f1-fd04-4c74-a7fb-55e26720372a

> FDA 483 for SUN PHARMACEUTICAL INDUSTRIES INC on July 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUN PHARMACEUTICAL INDUSTRIES INC
- Inspection Date: 2026-07-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: SUN PHARMACEUTICAL INDUSTRIES INC was cited for significant failures in conducting clinical investigations according to protocol and for inadequate monitoring. The firm failed to ensure required Hepatitis B core antibody testing for subject eligibility was performed, impacting 93 subjects across two studies. Additionally, systemic deficiencies were noted in the sponsor's monitoring program, which failed to promptly identify and correct investigator non-compliance and ensure adequate completion of protocol-required questionnaires.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-inc/35896832-2f85-4257-b499-6aa39d1d5f3b

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248