# FDA 483 - Amneal Complex Products Research LLC - April 18, 2018

Source: https://www.keypedia.com/records/483/amneal-complex-products-research-llc/275cbd5c-4c66-4ecc-86d3-ceba55388f0b

> FDA 483 for Amneal Complex Products Research LLC on April 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Complex Products Research LLC
- Inspection Date: 2018-04-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Kasiya Pharma, LLC in Bridgewater, NJ, revealed two significant issues. The firm failed to thoroughly review out-of-specification (OOS) investigations, specifically regarding unknown peaks in samples, and lacked written procedures for its quality control unit's responsibilities, including AQL inspections.

## Related Officers

- [CSO](https://www.keypedia.com/people/nancy-f-scheraga/7ab7500d-901f-4953-95a7-4a2b22488f04)

Company: https://www.keypedia.com/companies/amneal-complex-products-research-llc/a2be8996-ba6b-481d-b935-b75129500758

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