# FDA 483 - ALI Pharmaceutical Manufacturing LLC - May 03, 2024

Source: https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/102d7b3d-d9ab-490f-9da6-b177fa57520e

> FDA 483 for ALI Pharmaceutical Manufacturing LLC on May 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALI Pharmaceutical Manufacturing LLC
- Inspection Date: 2024-05-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of ALI Pharmaceutical Manufacturing, LLC in Omaha, NE, a human drug substance manufacturer, revealed significant deficiencies in laboratory controls. The firm was cited for invalidating out-of-specification (OOS) results without scientific justification and for inadequate investigations into critical deviations and batch failures, including a repeat observation. These issues indicate a lack of robust quality control and investigation processes.

## Related Documents

- [483 - 2017-12-01](https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/2cd46e70-9b2a-475f-92d5-516cc6921f0a)
- [483 - 2022-10-03](https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/dd111a0f-1896-4c7d-aea0-dbd4f3efc866)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.keypedia.com/companies/ali-pharmaceutical-manufacturing-llc/d3d0fcce-e7cb-4f71-8042-2726fd64e8a8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8