# FDA 483 - Amneal Pharmaceuticals, LLC - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-llc/7fee22fc-0cc6-4ca6-bb36-459b7511bd58

> FDA 483 for Amneal Pharmaceuticals, LLC on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals, LLC
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Amneal Pharmaceuticals, LLC in Branchburg, New Jersey, a finished product manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included unrecorded deviations from production procedures, insufficient physical separation leading to potential cross-contamination, and a failure to thoroughly review unexplained discrepancies in laboratory testing. These issues indicate a need for improved adherence to established protocols and facility controls.

## Related Officers

- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Investigator](https://www.globalkeysolutions.net/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.globalkeysolutions.net/companies/amneal-pharmaceuticals-llc/67b4a45a-cef3-4c19-bf2c-0c8bcf422d7e

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