# FDA 483 - ALI Pharmaceutical Manufacturing LLC - October 03, 2022

Source: https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/dd111a0f-1896-4c7d-aea0-dbd4f3efc866

> FDA 483 for ALI Pharmaceutical Manufacturing LLC on October 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALI Pharmaceutical Manufacturing LLC
- Inspection Date: 2022-10-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: ALJ Pharmaceutical Manufacturing, LLC in Omaha, NE, a drug substance manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in process validation, microbiological specifications, investigation procedures for deviations and out-of-specification results, and quality unit responsibilities. These issues indicate a lack of scientific soundness and control over manufacturing processes, potentially impacting product quality and purity.

## Related Documents

- [483 - 2017-12-01](https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/2cd46e70-9b2a-475f-92d5-516cc6921f0a)
- [483 - 2024-05-03](https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/102d7b3d-d9ab-490f-9da6-b177fa57520e)

## Related Officers

- [Brent M. Dehaan](https://www.keypedia.com/people/brent-m-dehaan/7a6af4a2-2566-48af-b59d-dd59008ff997)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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