# FDA 483 - Everest Life Sciences LLC - April 23, 2025

Source: https://www.keypedia.com/records/483/everest-life-sciences-llc/072cf8e7-0149-48bc-b870-b6a1b67e606c

> FDA 483 for Everest Life Sciences LLC on April 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Everest Life Sciences LLC
- Inspection Date: 2025-04-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Everest Life Sciences LLC in Plainsboro, NJ, a finished dose and API manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish adequate controls for process validation, equipment qualification, cleaning validation, laboratory testing, and computer systems. These issues indicate a lack of adherence to cGMP standards, potentially impacting drug product quality and purity.

## Related Documents

- [483 - 2011-02-18](https://www.keypedia.com/records/483/everest-life-sciences-llc/b9037723-dd31-4862-afc6-900984e2d868)
- [483_RESPONSE - 2011-02-18](https://www.keypedia.com/records/483_response/everest-life-sciences-llc/a6843c30-76b2-4d3d-9098-b27caef010dc)
- [483 - 2012-04-16](https://www.keypedia.com/records/483/everest-life-sciences-llc/ddc07e87-b096-4ee8-9419-c9e0b41216ab)

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/everest-life-sciences-llc/3f0de21d-b48b-4f8a-a8a2-3b6e376528f4

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